DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Application Status
2. Applicant’s amendment and response, submitted April 7, 2026, has been reviewed by the examiner and entered of record in the file. Claim 1 is amended.
3. Claims 5 and 6, drawn to a method for detaching a biological tissue surface, remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
4. The scope of the independent invention that encompasses the elected species, as set forth in the previous office action, is as follows:
A compound according to formula (1-1) of claim 1, wherein each occurrence of “A” is -CH2-CH2-, “R” is CH3; “n” is 4 to 12; and each “X” groups is a carboxylate moiety.
The non-elected compound species are presently withdrawn from consideration as drawn to non-elected subject matter.
5. Claims 1-4 and 7 are under examination with the scope of the independent invention and are the subject of this Office Action.
Priority
6. Applicant has not filed an English language translation of foreign priority JP Application No. 2020-216704. It is suggested that a certified translation of every foreign benefit application or Patent Cooperation Treaty (PCT) application not filed in English be submitted. See 35 U.S.C. 119(b)(3) and 372(b)(3) and 37 CFR 1.55(g)(3)(i) and 41.154(b). A showing of priority that relies on a non-English language application is prima facie insufficient to overcome an intervening reference if no certified translation of the application is on file. See 37 CFR 41.154(b) and 41.202(e).
Specification
7. Applicant’s submission of the corrected abstract of the disclosure on April 7, 2026 is sufficient to overcome the previous objection.
Claim Objections
8. Claim 1 is objected for the following minor informalities:
(a) The term “and” is missing after the term “tetradecyl group,” and before the recitation of “n is an integer of 4 to 100;” in lines 7-8.
(b) The term “wherein” should be added before the recitation of “at least one A is an ethylene group,” in line 9.
(c) The term “and” is missing after the term “tetradecyl group,” and before the recitation of “n is an integer of 4 to 100;” in lines 15-16.
(d) The term “wherein” should be added before the recitation of “at least one A is an ethylene group,” in line 17.
Previous Claim Rejections - 35 USC § 112(b)
9. Claims 1-4 and 7 were previously rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention, regarding the recitation of “… at least one of n As is an ethylene group;” is confusing because it is not clear what is intended by “n As.”
10. In view of Applicant’s amendment to replace the recitation of “… at least one of n As is an ethylene group;” with the limitation: “at least one A is an ethylene group,” the previous indefiniteness rejection is withdrawn.
New Claim Rejections - 35 USC § 112(b)
11. The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
12. Claims 1-4 and 7 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
13. This rejection is newly applied as a result of Applicant’s amendment to claim 1.
14. Claim 1 is rejected as being confusing regarding the recitation of “formula (1-1) or (1-2)” in line 1 when referring to the structural formulae of compound (Z), and then going on to label each of said formulae differently, i.e.: “[Chem. 1-1]” and “[Chem. 1-2]” (see line 2 and line 10). Each structural formula should be labeled/ referred to with just one identifying name throughout the claim for purposes of clarity and consistency.
Previous Claim Rejections - 35 USC § 112(a)
15. The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
16. Claims 1-4 and 7 remain rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
17. This rejection has been modified as necessitated by Applicant’s amendment to claim 1.
18. The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, at the time the application was filed, had possession of the claimed invention. In particular, support cannot be found for the full scope of compounds of formulas (1-1) and (1-2), as instantly claimed.
19. The MPEP §2163 states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed by him. In the case of chemical entities, Applicant's attention is further directed to Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559 (Fed. Cir. 1997), cert. denied, 523 U.S. 1089, 118 S. Ct. 1548 (1998), which notes that an adequate written description requires a precise definition, such as by structure, formula, chemical name, or physical properties, “not a mere wish or plan for obtaining the claimed chemical invention.” While the court recognizes that, “[i]n claims involving chemical materials, generic formulae usually indicate with specificity what the generic claims encompass” (Id.), it is also recognized that for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim and/or the genus must be sufficiently detailed to show that applicant was in possession of the claimed invention as a whole (see Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555 (Fed. Cir. 1991)). If a genus has substantial variance, the disclosure must present a sufficient number of representative species that encompass the genus in order to adequately describe the genus (i.e., the disclosure must describe a sufficient variety of species to reflect the variation within that genus). See MPEP § 2163. Otherwise, as stated by the court in Ariad Pharmaceuticals, Inc., v. Eli Lilly and Company (Fed. Cir. 2010), “a generic claim may define the boundaries of a vast genus of chemical compounds, and yet the question may still remain whether the specification, including original claim language, demonstrates that the applicant has invented species sufficient to support a claim to a genus.
20. In the instant case, it is evident that compound “Z” embraced by the genus of formula (1-1) or genus of formula (1-2) of claim 1 has substantial variance. In this case, A can be any alkylene group from C2-C4, and when combined with the oxo group, can be repeated up to 100 times. Indeed, the genera are virtually without limit, embracing hundreds of millions of potential compounds bearing little structural resemblance to one another. Yet, the instant Specification describes only five structurally related compound species, i.e., Compounds Z-1, Z-2, Z-3, Z-4, and Z-5 (i.e., see preparation in Examples 1-5 at pages 19-24).
21. While the MPEP does not define what constitutes a sufficient number of representative species, the courts have indicated what does not constitute a representative number of species to adequately describe a broad generic. For example, in In re Gostelli, the courts determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gostelli, 872 F.2d 1008 (Fed. Cir. 1989). In the instant case, it is similarly determined that the disclosure of five structurally related compounds does not adequately describe a subgenus embracing hundreds of millions of additional compound species bearing no structural relationship with those five disclosed compounds. That is, the Specification does not disclose a sufficient variety of species to reflect the extreme variance in the genus.
22. The description requirement of the patent statue requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736, F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does “little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate”). Accordingly, it is deemed that the specification fails to provide adequate written description for the genus of the claims and does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention.
As such, claims 1-4 and 7 are rejected.
Response to Arguments
23. Applicant argues that in view of the amendments to claim 1, the rejection under 35 USC 112(a) for failing to comply with written description is rendered moot.
Applicant alleges that a comparison between the compound (Z) recited in amended claim 1 and the compounds (Z-1) to (Z-5) described in the examples of the present specification shows that the compound (Z) of amended Claim 1 is sufficiently limited. Applicant argues that support can be found for the scope of compounds of formulas (1-1) and (1-2), as instantly claimed.
24. Applicant's arguments have been fully considered but they are not persuasive. Applicant’s instant compound Z, represented by Formula 1-1 or Formula 1-2 embraces an extremely large scope of compounds with repeating alkoxy moieties that number in the hundreds.
The recited genera are broad and virtually without limit, embracing hundreds of millions of potential compounds. Yet, the instant Specification describes only five structurally related compound species, i.e., Compounds Z-1, Z-2, Z-3, Z-4, and Z-5 (i.e., see preparation in Examples 1-5 at pages 19-24), such that the scope of compounds embraced by the claims are not commensurate in scope with the compounds prepared and disclosed by Applicant. It is suggested to limit the claims to Z-1, Z-2, Z-3, Z-4, and Z-5.
Previous Claim Rejections - 35 USC § 102
25. Claims 1-4 and 7 were previously rejected under 35 U.S.C. 102(a)(2) as being anticipated by Schellengberg et al., U.S. 6,020,373 A, (cited on Applicant’s IDS of June 23, 2023).
26. In view of Applicant’s amendment to the claims, the previous anticipation rejection has been overcome and is withdrawn.
Conclusion
27. Claims 1-7 are pending. Claims 5 and 6 are presently withdrawn from consideration as directed to a non-elected invention. Claims 1-4 and 7 are rejected. No claim is currently allowable.
28. THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
29. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JANET L COPPINS whose telephone number is (571)272-0680. The examiner can normally be reached Monday-Friday 8:30AM-5PM EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L Clark can be reached at 571-272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JANET L COPPINS/Examiner, Art Unit 1628
/AMY L CLARK/Supervisory Patent Examiner, Art Unit 1628
Prosecution Insights