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should present the best case with all the relevant reasons, issues, and evidence so that all such rejections can be withdrawn if applicant provides appropriate convincing arguments and/or evidence in rebuttal.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.
{ 14 comments… read them below or add one }
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.
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.
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”.
Hi Cw,
What do you think is the right answer? A or C? thanks.
Bo
Based upon my fact pattern, A was correct. for the reasons cited above.
Both A & C seemed appealing to me. The written discription was not proper to begin with
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…
I got this Q. I chose teh answer A – withdraw both rejections. I passed.
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.
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?
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.
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.
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.
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.