Q) Chemical Claim (MPEP 2100)

by patentbar on August 7, 2008 · 54 comments

in Exam Questions

Reported on the test: An application had claimed a chemical that was useful for relieving headaches. The application did not disclose how to make said chemical. Examiner rejects claim on enablement and written description. Applicant shows that a PHOSITA would know how to make said chemical and points formulas and technical data in the spec.

A. Examiner should withdraw both rejections in light of applicant’s submissions.
B. Examiner should withdraw enablement rejection, but keep written description as the application does not show how to make said chemical.
C. Examiner should withdraw both rejections as neither were proper to begin with.

Look at 2164.04 last 2 paragraphs “In accordance with the principles of compact prosecution, if an enablement rejection is appropriate, the first Office action on the merits should present the best case with all the relevant reasons, issues, and evidence so that all such rejections can be withdrawn if applicant provides appropriate convincing arguments and/or evidence in rebuttal. Providing the best case in the first Office action will also allow the second Office action to be made final should applicant fail to provide appropriate convincing arguments and/or evidence…. In other words, the examiner should always look for enabled, allowable subject matter and communicate to applicant what that subject matter is at the earliest point possible in the prosecution of the application.

The applicant will probably need to show evidence to rebut other than an argument. But if the evidence of Phosita knowledge is available the rejections should be removed. I would think the key is in the rejection language.

MPEP 2161 “the Federal Circuit reaffirmed that under 35 U.S.C. 112, first paragraph, the written description requirement is separate and distinct from the enablement requirement and gave an example thereof.). An invention may be described without the disclosure being enabling (e.g., a chemical compound for which there is no disclosed or apparent method of making), and a disclosure could be enabling without describing the invention (e.g., a specification describing a method of making and using a paint composition made of functionally defined ingredients within broad ranges would be enabling for formulations falling within the description but would not describe any specific formulation).”

This means that by showing that a Phosita can make and use the chemical, the enablement requirement is satisfied and so that rejection should be dropped. However, the above facts do not tell us if the written disclosure requirement is satisfied, so that rejection may stay. So B is the correct answer.

{ 54 comments… read them below or add one }

1 NedNo Gravatar January 8, 2009 at 11:13 am

Are you sure about B?? “how to make Chemical” would go to enablement, written description goes to proof of being in possession of the invention.

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2 BigBadVoodoDaddyNo Gravatar July 1, 2011 at 11:25 am

Ned – I agree, A should be the answer

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3 JustinNo Gravatar March 23, 2009 at 10:02 am

Obviously, we’re missing a lot of particulars in the question, but see section 2163, “An applicant may show possession of an invention by disclosure of drawings or structural chemical formulas that are sufficiently detailed to show that applicant was in possession of the claimed invention as a whole. See, e.g., Vas-Cath, 935 F.2d at 1565….” Although the written description and enablement requirements are separate, they can also be satisfied with the same arguments.

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4 CWNo Gravatar June 11, 2009 at 1:26 pm

I got this question, and I think that the guidance above is incorrect. The fact pattern shows that the applicant rebuts the examiners arguments by showing that the method of making the chemical is common in the art, along with evidence. I believe that the evidence, not only satisfies the enablement issue, but also the written description requirement. The chemical is what is claimed, and if the method of manufacture is common in the art, then the examiner would not be able to argue that the applicant “did not posses the invention”.

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5 cindyNo Gravatar June 18, 2009 at 1:24 pm

Hi Cw,
What do you think is the right answer? A or C? thanks.
Bo

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6 CWNo Gravatar June 18, 2009 at 2:29 pm

Based upon my fact pattern, A was correct. for the reasons cited above.

7 cindyNo Gravatar June 19, 2009 at 12:56 pm

Both A & C seemed appealing to me. The written discription was not proper to begin with

8 CWNo Gravatar June 19, 2009 at 12:59 pm

Couldn’t reply to the last post.

The rejection on written description was only because if the applicant could not show that it was enabled, he could not possess it. However, if the prior art, and skill in the art shows that making the chemical is common knowledge, the examiner could not maintain an objection that the inventor did not posses the invention…

9 IrisNo Gravatar October 29, 2009 at 7:52 pm

I got this Q. I chose teh answer A – withdraw both rejections. I passed.

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10 ZanNo Gravatar July 24, 2012 at 2:20 pm

I would choose A. If all that is being claimed is the USE, then lack of description on how to make the chemical is not basis for rejection.

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11 KeithNo Gravatar November 14, 2009 at 7:12 pm

Correct answer must be B, accoeding to the 2164 last para.

2164 The Enablement Requirement [R-2]

Last Para..

Furthermore, when the subject matter is not in the specification portion of the application as filed but is in the claims, the limitation in and of itself may enable one skilled in the art to make and use the claim containing the limitation. When claimed subject matter is only presented in the claims and not in the specification portion of the application, the specification should be objected to for lacking the requisite support for the claimed subject matter using Form Paragraph
7.44. See MPEP § 2163.06. This is an objection to the specification only and enablement issues should be treated separately.

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12 GoJacketsNo Gravatar November 15, 2009 at 1:01 pm

are you sure the wording of B (above) is how it was worded on the exam? it doesn’t seem to make sense…

B. Examiner should withdraw enablement rejection, but keep written description as the application does not show how to make said chemical.

If the evidence the applicant presented was about how to make it, I’d agree that might merit a withdrawal of a rejection based on enablement. But the answer says “…but keep the written description rejection because he still hasn’t shown how to make the chemical” – isn’t that what he just did? he showed that PHOSITA’s know how to make it, right? are we sure the answer choice didn’t say “…but keep the written description rejection b/c applicant still hasn’t described the invention,” or “because his reply was not responsive to the written description rejection?”

also i’m not sure about the previous poster’s conclusion that if you’ve shown how to make the composition, you will have necessarily decribed the invention and, therefore, have satisfied written description. that seems to be the very conclusion that 2161 is warning you not to make. plus, is it just a coincidence that 2161, like this question, uses the example of a chemical compound to illustrate the distinction?

thoughts?

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13 calvinNo Gravatar March 22, 2010 at 3:12 am

I have to disagree with everyone above because I don’t see how C cannot be the correct answer based on on the following MPEP passages directly stating the examiner has the initial burden to show why PHOSITA would not recognize the specification as having a both written description and enablement. The simple examiner rejection without showing why is improper.

MPEP 2161 I. A. Original Claims
There is a strong presumption that an adequate written description of the claimed invention is present when the application is filed. In re Wertheim, 541 F.2d 257, 263, 191 USPQ 90, 97 (CCPA 1976) (“we are of the opinion that the PTO has the initial burden of presenting
evidence or reasons why persons skilled in the art would not recognize in the disclosure a description of the invention defined by the claims”).

MPEP 2163.04 Burden on the Examiner with Regart to the Written Description Requirement
A description as filed is presumed to be adequate, unless or until sufficient evidence or reasoning to the contrary
has been presented by the examiner to rebut the presumption. See, e.g., In re Marzocchi, 439 F.2d 220, 224, 169 USPQ 367, 370 (CCPA 1971). The examiner,
therefore, must have a reasonable basis to challenge
the adequacy of the written description. The examiner has the initial burden of presenting by a preponderance
of evidence why a person skilled in the art would not recognize in an applicant’s disclosure a description of the invention defined by the claims.

MPEP 2164.04 Burden of the Examiner Under the Enablement Requirement
In order to make a rejection, the examiner has the initial burden to establish a reasonable basis to question
the enablement provided for the claimed invention.

must be taken as being in compliance with the enablement requirement of 35 U.S.C. 112, first paragraph, unless there is a reason
to doubt the objective truth of the statements contained
therein which must be relied on for enabling support. Assuming that sufficient reason for such doubt exists, a rejection for failure to teach how to make and/or use will be proper on that basis.

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14 kingkhanNo Gravatar July 11, 2010 at 5:41 am

This is showing up on recent exams for sure and we have answers all over the place. We really need this one hammered out to a conclusion. It showed up on my exam in June 2010 and I know two people who saw it in March and may of 2010. I guessed C but I have no clue if that was right. I missed passing by two questions.

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15 Derek WalkerNo Gravatar July 14, 2010 at 9:01 pm

I took the exam today (July 14, 2010), and got this question. The wording of my question referred to as a Compound as opposed to a Chemical. I had no idea and did a complete guess. I think I suggested that because the description did not show how to make or use the compound (though a POSITA would already know how to use) that both REJECTIONS (didn’t see language about Objections) would be maintained. Again, only a guess. BTW, I did pass.

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16 PCTMasterNo Gravatar July 18, 2010 at 11:18 pm

it would probably help if somebody posted the complete question. i’m taking this test on next monday and if i see this problem I’ll come back and post it. but i think it’s stupid to speculate when you have an incomplete question prompt and only 3 out of 5 answer choices.

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17 MattNo Gravatar August 7, 2010 at 11:45 pm

I’m fairly confident that (C) would be correct. The spec originally contained the formulas and “technical data,” which satisfies MPEP 2163.02:

“An objective standard for determining compliance with the written description requirement is, “does the description clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed… Whenever the issue arises, the fundamental factual inquiry is whether the specification conveys with reasonable clarity to those skilled in the art that, as of the filing date sought, applicant was in possession of the invention as now claimed.”

“Possession may be shown in a variety of ways including description of an actual reduction to practice, or by showing that the invention was “ready for patenting” such as by the disclosure of drawings or structural chemical formulas that show that the invention was complete.”

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18 daveNo Gravatar February 7, 2011 at 12:13 am

Application involving a Chemical claims with no description of how to make the compound but evidence applicant was in possession of the compound. The application did not disclose how to make said chemical. Examiner rejects claim on enablement and written description. Applicant shows that a PHOSITA (person having ordinary skill in the art)would know how to make said chemical and points to formulas and technical data in the spec.
A. Examiner should withdraw both rejections in light of applicant’s submissions.
B. Examiner should withdraw enablement rejection, but keep written description as the application does not show how to make said chemical.
C. Examiner should withdraw written description rejection but keep enablement rejection because applicant was in possesiion of the compound (?)
D. Examiner should withdraw both rejections as neither were proper to begin with. (I chose this).
E. None of the above (?)
from http://www.intelproplaw.com/ip_forum/index.php/topic,14840.0.html

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19 Joe C.No Gravatar March 17, 2011 at 9:28 pm

I have a problem with the big picture of this issue. One of the affects of receiving patent protection is that one has to disclose his invention to the public after his patent term has ended. I believe you have to have more substance to a patent for public disclosure than just a mere statement than “A PHOSITA knew how to make it.” At the very least, I would presume that the PHOSITA authority would have to somehow provide the disclosure of how it was made sooner or later to the public so they would now how to make it themselves.

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20 Joe C.No Gravatar March 17, 2011 at 9:42 pm

So, essentially I am saying I have a problem with those answers that suggest that a PHOSITA statement would be good enough to overcome BOTH a 112 rejection AND written disclosure requirement, because in the end, one needs to disclose a patent satisfactorily in order for the public to be able to duplicate it and use it properly.

21 patenttipsNo Gravatar March 18, 2011 at 4:01 pm

good point….not sure

22 InterenNo Gravatar March 25, 2011 at 9:23 am

Yes, Patent is an exchange between the public and patentee. Full disclosure Vs limited exclusive rights. But the public will still have to appreciate/ utilize the patent through PHOSITA. So PHOSITA is more relevant when concerning disclosure, not the Joe plumber.

23 BigBadVoodoDaddyNo Gravatar July 1, 2011 at 11:21 am

Dave, thanks for the post.
However I disagree that the fact that the formula was stated in the original spec makes the rejection improper.
For example the formula could be a generic one, or an incomplete one – which would require an explanation or other limitations etc. So the rejection would be proper until it was overcome with argument.

Same for the enablement – if PHOSITA could not make or use, then the rejection is proper. But may be overcome by argument and facts.

Hence both rejections are correct to begin with.

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24 EyestrainedNo Gravatar June 22, 2013 at 8:01 pm

Got this. Don’t remember how I answered. 06/21/13.

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25 LarryNo Gravatar March 25, 2011 at 11:21 am

The question, as presented, doesn’t say the applicant merely stated or argued that a PHOSITA could make and use based on the spec; it says he “shows”. To me that includes evidence such as a declaration. In light of this I think statement A is correct.

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26 BigBadVoodoDaddyNo Gravatar July 1, 2011 at 11:14 am

Agree

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27 HNo Gravatar March 31, 2011 at 3:48 pm

MPEP 2163 – An adequate written description of a chemical invention also requires a precise definition, such as by structure, formula, chemical name, or physical properties, and not merely a wish or plan for obtaining the chemical invention claimed.

Based on this, if the spec included a chemical formula, I don’t think there should have been a written description rejection in the first place.

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28 jellybeanNo Gravatar April 3, 2011 at 3:27 am

i saw this question on the april 1st test. dave’s post of the question is pretty accurate, but i think there are more specifics in the fact pattern that make the question less confusing. i don’t recall the specific wording, but basically the written description as filed had the chemical formulas in it and other technical details. However, nothing is said about enablement as filed. So the examiner is right to reject on lack of enablement because nothing is specified. After the applicant submits that a PHOSITA would know how to make the chemical, then this satisfies the enablement requirement. So with both requirements being met for 112 paragraph 1, I chose A as the answer as well.

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29 OverworkkedNo Gravatar April 28, 2011 at 2:51 pm

VARIANT on 4/27/2011 E8R8:

Application for compound Z to treat cancer. No disclosure of how to make Z. Prior art discloses Z but also does not disclose how to make Z.

Examiner wants to make a 112, first paragraph rejection for enablement, how should he do this?

A. 112 enablement only b/c no enabling of phosita
B. 112 enablement + 112 written descripton b/c spec + prior art doesn’t enable phosita (my answer)
C. likely wrong
D. likely wrong
E. likely wrong

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30 BigBadVoodoDaddyNo Gravatar July 1, 2011 at 11:09 am

That looks like it is correct. It is (as always) confusing when one reads so many varying opinions. My two cents.

1. Description – 2163 A.
If the SPEC (original description) do not support the claims. Then a 112 rejection on description is ok to make. This is regardless if the prior art describes it. Absent an explicit statement that says that it is very common in the art, the assumption would have to be that the rejection is proper. e.g. a biomolecule (as quoted in the mpep) may be described elsewhere, but if it is not described with sufficient detail in the spec, the spec is lacking description (applicant does not show posession and PHOSITA may not immediately be able to envision the invention) and hence can be rejected. This may be overcome later on (e.g – by showing and explaing the formula in the spec coupled with other facts and details), however the rejection is proper.

2. Enablement – make and use.
If PHOSITA cannot make or use – enablement rejection for sure.
This also can be overcome by explaining by argument. However the rejection is proper.

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31 MirandaNo Gravatar April 7, 2012 at 5:31 pm

Voodoodaddy is correct. Got both variants today. In this variant, the fact pattern specifically told you he sufficiently showed possession of the compound, and therefore written description requirement was met.

32 FredsNo Gravatar June 1, 2011 at 11:46 pm

Here is my take on this.
First the enablement requirement says the disclosure must enable PHOSITA make+use the invention. This doesn’t mean a disclosure of how to make the invention is required when such is a routine work or having been enabled by PA. This can happen when the structure or composition is sufficiently disclosed and making is again just routine work. For instance, for computer program to the extent it is still patentable after Bilski, disclosure of high level functionality is sufficient, detail implementation of source code is not required to be disclosed.
Second, the written description requirement has two purpose, police function to prevent bad gamesmanship in amendements (See Gentry Gallery) and the finish line function (See Eli Lilly), as established by law. My take is if structure and utility with make being routine in the art, as described by the fact pattern here, is sufficiently disclosed the written description requirement is also satisfied.
Now they may vary the fact patten and answer choices, but I think this should be the controlling rationale as guidance to the correct answer. I hope this helps.

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33 BobNo Gravatar August 3, 2011 at 2:05 am

Got this on 8/2/11. Went with the answer about removing the rejections in light of the new information.

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34 maggieNo Gravatar August 27, 2011 at 1:43 pm

112 p1 Q: Difference between enablement and written description/chemical 8/24/2011

An application had claimed a chemical that was useful for relieving headaches. The application shows the formula but did not disclose how to make chemical. No prior art shows how to make the chemical in question either. What is an appropriate response from the Examiner? –answer choices (A) Reject written description (B) reject both written description and enablement (C) enablement is distinct from written description requirement. (D) require enablement request from applicant

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35 NickNo Gravatar September 7, 2011 at 5:03 pm

Got this question on 9/7/11.

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36 patentgeekchickNo Gravatar September 22, 2011 at 8:41 pm

Got this. Can’t remember a thing =/
I thought Written Description was ok. Wouldn’t know…

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37 GregNo Gravatar October 11, 2011 at 4:58 pm

To Maggie, the answer is (C): “enablement is distinct from written description requirement”

MPEP 2161, Subheading “The Three Requirements are Seperate and Distinct From Each Other”

“The written description requirement is seperate and distinct from the enablement requirement. An invention may be described without the disclosure being enabling, and a disclosure could be enabling without describing the invention.”

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38 ReadyAndWillingNo Gravatar October 16, 2011 at 8:49 pm

“Enablement is distinct from written description requirement” is a description in the MPEP to better understand how to interpret 112. It is not a response by an examiner. The examiner must reject under both. No formula, no PHOSITA knowledge thus no enablement. No formula, no proof of possession (unless otherwise stated) no proper description as the description functions as proof of possession in this light.

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39 maggieNo Gravatar November 15, 2011 at 5:05 pm

112 p1 distinct from written description requirement
Enablement Q: Is the invention able to practice without undue experimentation?
Written Description: Q: Is the inventor in possession of claimed invention at the time of filing?

The application shows the formula but did not disclose how to make chemical. No prior art shows how to make the chemical in question either. What is an appropriate response from the Examiner?
(A) Reject written description (HAS FORMULA = NO)
(B) reject both written description and enablement (NO inventor has FORMULA and YES public is not enabled so, overall –> NOT Correct)
(C) enablement is distinct from written description requirement. (True MPEP 2161)
(D) require enablement request from applicant (True need to enable public to get patent granted but maybe not best answer)

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40 RickyNo Gravatar November 1, 2011 at 3:10 pm

Guys, I think (A) is correct.

” Argument Only” is enough to rebut enablement rejection if it is convicing enough. For example the practioner may argue that an undergraduate student major in chemistry would know how to make it so long as he/she sees the fomular/structure, and PHOSITA in this field are those with master degree.

MPEP 2100-198 –“In accordance with the principles of compact prosecution, if an enablement rejection is appropriate, the first Office action on the merits should present the best case with all the relevant reasons, issues, and evidence so that all such rejections can be withdrawn if applicant provides appropriate convincing arguments and/or evidence in rebuttal.”

Therefore factual evidence is not 100% necessaary.

In addition formulas and technical data in the spec would be enough to show possesion and rebut written description.

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41 RickyNo Gravatar November 1, 2011 at 3:20 pm

Also I remenber an old exam question (02 or 03…) asking what CANNOT rebut enablement rejection, and the answer is something like “amending a picture”. “Arguement” is one of the 5 answers, that means argument can rebut.

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42 RickyNo Gravatar November 1, 2011 at 11:39 pm

2003 Aprial Am Q49
An examiner has advanced a reasonable basis for questioning the adequacy of the enabling disclosure in the specification of your client’s patent application, and has properly rejected all the claims in the application. The claims in the application are drawn to a computer program system. In accordance with the USPTO rules and the procedures set forth in the MPEP, the rejection should be overcome by submitting _____________
(A) factual evidence directed to the amount of time and effort and level of knowledge required for the practice of the invention from the disclosure alone.
(B) arguments by you (counsel) alone, inasmuch as they can take the place of evidence in the record.
(C) an affidavit under 37 CFR 1.132 by an affiant, who is more than a routineer in the art, submitting few facts to support his conclusions on the ultimate legal question of sufficiency, i.e., that the system “could be constructed.”
(D) opinion evidence directed to the ultimate legal issue of enablement.
(E) patents to show the state of the art for purposes of enablement where these patents have an issue date later than the effective filing date of the application under consideration.

The answer is (A). (B) is incorrect not because it is “arguement”, but “Arguments of Counsel,”. It’s kind of language game here……My best take is, to rebut enablement rejection, only arguement from applicants is allowed because their knowledge in this field. Arguement from counsel is not enough.

correct me if I am wrong.

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43 SolNo Gravatar April 6, 2012 at 10:03 pm

B is wrong not because of it is an argument or someone’s argument.

B is wrong because this false statement embeded therein: “alone, inasmuch as they can take the place of evidence in the record”

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44 RickyNo Gravatar November 1, 2011 at 11:44 pm

In addition, unfair game for enablement rejection:

The examiner could use later publication/patent to support “non-enable”

but you CANNOT use such later publication/patent to show “enable”. (E) in above question.

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45 maggieNo Gravatar November 2, 2011 at 11:42 am

Factual evidence ALWAYS trumps arguments so A is the best answer.

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46 SolNo Gravatar April 6, 2012 at 10:05 pm

You alwasy need to submit rebuttal argument. The argument needs to be based on evidence (factual or opinion,from the application as filed or from somewhere else)

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47 RTNo Gravatar May 11, 2012 at 12:45 pm

Got it 5-10-12

I’m still not sure of the right answer…

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48 SabrinaNo Gravatar May 11, 2012 at 1:20 pm

05-10-12: Got a variation asking what the examiner should do as a first office action given: 1. no formula and no way for phosita to know how to make it, but 2. evidence that inventor was in poss’n at time of application.
answer choices included just enablement rejection, just written description rejection, no rejection, and combination of both (can’t recall the fifth choice). I picked the answer that said just enablement rejection because written description is satisfied because there is evidence that inventor was in poss’n at time of application.

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49 jkpatentlawNo Gravatar June 14, 2012 at 11:48 am

Agreed!

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50 peeJNo Gravatar May 23, 2012 at 10:38 pm

anyone have any updates on this question? I’m still not sure what the correct answer is based on the language in the foregoing questions

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51 NarNo Gravatar July 4, 2012 at 4:59 pm

I think if something lacks description then it is not enabling. Enablement is a requirement that allows someone to make and use the invention. Therefore lack of written description in this case would also lead to lack of enablement. If the inventor or practioner points out that the POSITHA could know how to make the invention and also points to specific formula, drawing etc. this would meet the enablement requirement. See MPEP 2163.02 on possession of the invention.

Whenever the issue arises, the fundamental factual inquiry is whether the specification conveys with reasonable clarity to those skilled in the art that, as of the filing date sought, applicant was in possession of the invention as now claimed. See, e.g., Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991). An applicant shows possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention. Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997). Possession may be shown in a variety of ways including description of an actual reduction to practice, or by showing that the invention was “ready for patenting” such as by the disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the applicant was in possession of the claimed invention

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52 MojoNo Gravatar September 23, 2012 at 6:03 pm

Chemical compound variant 9/23/12

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53 RandomNo Gravatar October 15, 2012 at 8:41 pm

Got this one today.

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54 EyestrainedNo Gravatar June 22, 2013 at 7:55 pm

2 different Chemical Compound questions. One asked what needed to be supplied (i.e. chemical formula)… 06/21/13.

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