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 .
With the amendments filed 9/16/26, claims 2-5, 8-9, and 11-13 are pending and examined on the merits.
Priority – Foreign – Certified Copy Filed 9/9/26, Acknowledged
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed (9/9/26) - CN202111290823.9, filed in People’s Republic of China on 11/2/21.
Election/Restrictions-Withdrawn Following Amendments
Claim Rejections - 35 USC § 101 – Judicial Exception, Naturally Occurring Product
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Product claims 2-4 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a naturally occurring product without significantly more. The claim(s) recite(s) naturally occurring fibrinogen-like protein 1 SEQ ID NOS: 1 and 3 (positions 48-290 of SEQ ID NO: 1) and their respective nucleic acids encoding such SEQ ID NOS: 2 and 4. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims are simply drawn to the isolated fragments themselves as they exist in nature within the larger fibrinogen-like protein 1, without any further modification thereto. See e.g. SEQ ID NO: 1, the 312mer naturally occurring fibrinogen-like protein 1 (KR 2015037321 (Korean Institute of Radiological and Medical Science; 04-08-2015)) comprising instant fragments therein peptide SEQ ID NOS: 1, 3.
Claim Rejections - 35 USC § 112(a)(i)/(pre-AIA ) – Written Description
The following is a quotation 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.
Claims 5, 8-9, and 11-13 are 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 claim(s) contains 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
To provide evidence of possession of a claimed genus, the specification must provide sufficient distinguishing/identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof.
In this case (see instant PGPUB 20240352090 test data as to peptide SEQ ID NOS: 1, 3): 1. Method of Treatment (Claim 5): Inhibiting Thrombogenesis with peptide SEQ ID NO: 1 or 3, only shown in possession. As also recited in the related PCT written opinion (PCT/CN2021/128944):
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2. FLP1 Modified with a Structure for Crossing the BBB (Claims 8, 11, and 12): Only those brain-targeting ligands claimed in claim 12 and described find support/possession therefore. Namely, RVG peptide, stearic-acid transferrin, and carrier protein E. Absent evidence to the contrary to guide what other structures may work to carry peptide SEQ ID NOS: 1 or 3 across the BBB.
In the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the claimed genus above – namely as to that treatable by peptide SEQ ID NO: 1 or 3 and those ligands capable of carrying such across the BBB.
Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111; clearly states that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry,whatever is now claimed." (See page 1117.) The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." (See Vas-Cath at page 1116).
With the exception of those noted, the skilled artisan cannot envision the detailed chemical structure of the encompassed variants of structures capable of carrying peptide SEQ ID NOS: 1 or 3 across the BBB, and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016.
Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. §112 is severable from its enablement provision (see page 1115).
Claim Rejections - 35 USC § 112(d) – Failure to Further Limit & Improper Markush Group
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
I. Claim 4 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 4 is drawn to various products that may comprise the product of claim 2 (peptide SEQ ID NOS: 1 or 3), but without claiming any other elements UNLESS the preamble is intended to breathe life into the claim, for which further evidence is required to discern. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
II. Claim 4 is rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping (preamble) of different types of products is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: simply put . . . cassettes are not vectors are not bacteria are not cell lines. At a minimum each are structurally distinct products, even if also comprising peptide SEQ ID NO: 1 or 3.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
Claim Scope/Grammatical Observations
In claim 9, lines 2-3, the claims should simply be amended to --wherein the method comprises a further therapeutic agent.-- A standard therapeutic composition claim scope permitting additional therapeutic agents without limit. The language beyond ‘agent’ that such must be capable of combination is not necessary.
In claim 13, line 1, the comma after wherein should be removed for grammatical correctness.
Prior Art Made of Record But Not Relied Upon –
Potentially Allowable Subject Matter Scope
The related PCT written opinion (PCT/CN2021/128944) finds the use of peptide SEQ ID NOS: 1 or 3 novel and inventive for inhibiting thrombogenesis, and were the scope of the claims here amended thereto, such may equally here, pending the final, updated search of the prior art on that scope, if pursued:
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Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAURY AUDET whose telephone number is (571)272-0960. The examiner can normally be reached on M-Th. 7AM-5:30PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko Garyu can be reached on 571-270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MAURY A AUDET/Primary Examiner, Art Unit 1654
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