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 .
DETAILED ACTION
2. The election with traverse filed 01/05/2026 in response to the Office Action of 11/05/2025 is acknowledged and has been entered.
Applicant has elected Group I, claims 1-21, drawn to a phospholipid-photothermal nanoparticle having an antibody bound to the surface thereof, comprising; a phospholipid membrane with entrapped photothermal nanoparticles; and an antibody specific for the surface protein of cancer cells, or a fragment thereof, which is bound to the surface of the phospholipid membrane.
Additionally, Applicant has elected the anti-Claudin 3 antibody comprising a light chain variable region of SEO ID NO: 7 and a heavy chain variable region of SEO ID NO: 15.
Upon review and reconsideration, SEQ ID NOs of claim 17 will be rejoined with SEQ ID NOs: 7 and 15 for examination.
Claims 1-25 are pending in the application. Claims 22-25 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 01/05/2026.
4. Claims 1-21 are currently under prosecution.
Election/Restrictions
5. Applicant's traversal of the propriety of the restriction and election requirement set forth in the Office action mailed 11/05/2025 is acknowledged.
Applicant’s arguments have been carefully considered but not found persuasive for the following reasons:
For the reasons set forth in the preceding Office action mailed 11/05/2025, the different inventions or different species thereof listed, as listed therein, do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2.
Then, in light of the grounds of rejection of the claims directed to the elected invention that follow, it is apparent that although the inventions appear to be linked by a common concept, or special technical feature, namely the claimed a phospholipid-photothermal nanoparticle having an antibody bound to the surface thereof comprising a phospholipid membrane with entrapped photothermal nanoparticles, and an antibody specific for the surface protein of cancer cells, which is bound to the surface of the phospholipid membrane, because the prior art, Walker et al. (WO 2012094727, published on 07/19/2012) teach phospholipid encapsulated gold nanoparticles are conjugated to monoclonal antibodies (and any minor differences in the subject matter claimed in the instant application would be seen as an obvious variation of subject matter described by the prior art), this technical feature that appears to link the inventive concepts of the different inventions does not constitute a special technical feature as defined by PCT Rule 13.1, as it does not define a contribution over the prior art.
Accordingly, the restriction and election requirement set forth in the Office action mailed 11/05/2025 is deemed proper and therefore made FINAL.
Priority
6. Applicant’s claim under 35 U.S.C. §§ 365(c) for benefit of the earlier filing date of application, is acknowledged.
Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file.
Improper Markush Grouping Rejection
8. Claim 17 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 § 706.03(y).
The Markush grouping of antibodies recited in claim 17 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: because the antibodies do not share a “single structural similarity”.
Claim Rejections - 35 USC § 112
9. 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.
10. 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.
11. Claims 1 and 10 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 pre-AIA the applicant regards as the invention.
Claim 1 recites “an antibody specific for the surface protein of cancer cells”. Since cancer cells have many surface proteins, it is unclear which surface protein is the claim referring to.
Claim 10 contains the trademark/trade name(s): Herceptin. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name(s) is/are used to identify/describe particular pharmaceutical formulation(s) and, accordingly, the identification/description is indefinite.
12. 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.
13. The following is a quotation of 35 U.S.C. 112 (pre-AIA ), first paragraph:
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.
14. Claim 17 is 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.
This is a “written description” rejection.
The considerations that are made in determining whether a claimed invention is supported by an adequate written description are outlined by the published Guidelines for Examination of Patent Applications Under the 35 U.S.C. 112, para. 1, ``Written Description'' Requirement (Federal Register; Vol. 66, No. 4, January 5, 2001; The 2015 Written Description Workshop materials; hereinafter “Guidelines”).
These guidelines state that rejection of a claim for lack of written description, where the claim recites the language of an original claim should be rare. Nevertheless, these guidelines further state, “the issue of a lack of written description may arise even for an original claim when an aspect of the claimed invention has not been described with sufficient particularity such that one skilled in the art would recognize that the applicant has possession of the claimed invention” (Id. at 1105). The “Guidelines” continue:
The claimed invention as a whole may not be adequately described if the claims require an essential or critical feature which is not adequately described in the specification and which is not conventional in the art or known to one of ordinary skill in the art. This problem may arise where an invention is described solely in terms of a method of its making coupled with its function and there is no described or art-recognized correlation or relationship between the structure of the invention and its function. A lack of adequate written description issue also arises if the knowledge and level of skill in the art would not permit one skilled in the art to immediately envisage the product claimed from the disclosed process.
With further regard to the proposition that, as original claims, the claims themselves provide in haec verba support sufficient to satisfy the written description requirement, the Federal Circuit has explained that in ipsis verbis support for the claims in the specification does not per se establish compliance with the written description requirement:
Even if a claim is supported by the specification, the language of the specification, to the extent possible, must describe the claimed invention so that one skilled in the art can recognize what is claimed. The appearance of mere indistinct words in a specification or a claim, even an original claim, does not necessarily satisfy that requirement. The disclosure must allow one skilled in the art to visualize or recognize the identity of the subject matter purportedly described. Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559, 43 USPQ2d 1398 (Fed. Cir. 1997). See also: University of Rochester v. G.D. Searle & Co., 69 USPQ2d 1886 1892 (CA FC 2004).
Thus, an original claim may provide written description for itself, but it must still be an adequate written description, which establishes that the inventor was in possession of the invention.
Claim 17 is directed to a genus of anti-Claudin3 antibodies comprising a miss-matched light chain and heavy chain.
The specification does not teach that an antibody comprises a miss-matched light chain and heavy chain would have or retain the activity or function of the antibody.
Given the fact that the claims are drawn to a genus of antibodies comprising a miss-matched light chain and heavy chain, which have no particular function or activity, there is no correlation between any one particularly identifying structural feature and any one particularly identifying functional feature. Consequently, it is submitted that the skilled artisan could not immediately envision, recognize or distinguish at least a substantial number of the genus of antibodies comprising a miss-matched light chain and heavy chain would have activity for treating cancer.
The specification does not teach that an antibody comprises a miss-matched light chain and heavy chain would have or retain the activity or function of the antibody. This is largely because each antibody comprising a miss-matched light chain and heavy chain has substantially varied structure and need not have any particular function or activity.
Guidelines states, “[p]ossession may be shown in a variety of ways including description of an actual reduction to practice, or by showing the invention was ‘ready for patenting’ such as by 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” (Id. at 1104). “Guidelines” further states, “[f]or inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus” (Id. at 1106); accordingly, it follows that an adequate written description of a genus cannot be achieved in the absence of a disclosure of at least one species within the genus. Moreover, because the claim encompass a genus of antibodies comprising a miss-matched light chain and heavy chain would have activity for treating cancer, which vary both structurally and functionally, an adequate written description of the claimed invention must include sufficient description of at least a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics sufficient to show that Applicant was in possession of the claimed genus. In this instance, factual evidence of an actual reduction to practice has not been disclosed by Applicant in the specification; Applicant has not shown the invention was “ready for patenting” by disclosure of drawings or structural chemical formulas that show that the invention was complete; and Applicant has not described distinguishing identifying characteristics sufficient to show that Applicant was in possession of the claimed invention at the time the application was filed.
Thus, it is submitted that the instant claims, and the disclosure describing the claimed subject matter, fails to satisfy the written description requirement set forth under 35 U.S.C. § 112, first paragraph.
15. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claim Rejections - 35 USC § 102
16. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
17. Claims 1-4, 7, 9, 11-15, 18 and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Walker et al. (WO 2012094727, published on 07/19/2012) evidenced by Vines et al. (Front Chem., 2019 Apr 5, 7:167, pages 1-16).
Claims 1-4, 7, 9, 11-15, 18 and 21 are herein drawn to a phospholipid-photothermal nanoparticle having an antibody bound to the surface thereof, comprising; a phospholipid membrane with entrapped photothermal nanoparticles; and an antibody or a fragment thereof specific for the surface protein of cancer cells, which is bound to the surface of the phospholipid membrane, wherein the photothermal nanoparticle is a gold nanoparticle.
Walker et al. teach phospholipid encapsulated gold nanoparticles are conjugated to monoclonal antibodies; see entire documents, e.g., abstract, claims 19-22.
For claim 2, gold nanoparticles can generate heat by absorbing light in the near-infrared region (NIR); see page 3-right col.-paragraph 2-3 of Vines et al.
For claim 4, Walker et al. teach that the phospholipids comprise one or more of: DPPC, DPPG, PG, PC and DSPE; see page 28 and claim 61.
For claims 7, 9 and 12-15, Walker et al. teach that a F(ab')2 fragment was generated and covalently linked to maleimide-PEG-DSPE through the thiol group of the cysteine residue of the fragment; see page 26-lines 23-24, page 31-lines 26-28, page 29-lines 1-3.
For claim 11, Walker et al. teach that the size of the particle is between about 5 nm and about 300 nm; see page 27-lines 18-22.
For claim 18, Walker et al. teach that the particle can be used to monitor the effectiveness of a cancer treatment; see page 4-lines 13-14, page 32-lines 4-5.
For claim 21, gold nanoparticles were able to localize to human gastric cancer tumors and induce thermal-mediated apoptosis and reduction in tumor volume following NIR irradiation; see last paragraph-left col.-page 9 of Vines et al.
Claim Rejections - 35 USC § 103
18. The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
19. The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
20. Claims 1, 5-6, 8, 10, 16 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Walker et al. (WO 2012094727, published on 07/19/2012) in view of Yang et al. (Biomolecules, 28 December 2019, vol. 10, no. 1, thesis no. 51, pp. 1-21, IDS) evidenced by Park et al. (US 20030143229, published on 07/31/2003) and Shiraiwa et al. (US 20220195045, filed on 08/02/2019).
Claims 8, 10 and 19-20 are herein drawn to the phospholipid-photothermal nanoparticle having an antibody bound to the surface thereof of claim 1, wherein the antibody or a fragment thereof is an anti-Claudin3 antibody.
The teachings of Walker et al. have been set forth in the above rejection of claims 1-4, 7, 9, 11-15, 18 and 21 under 35 U.S.C. 102(a)(1).
Walker et al. do not teach the antibody is an anti-Claudin3 antibody.
However, this deficiency is remedied by Yang et al.
Yang et al. teach an anti-Claudin3 monoclonal antibody embedded lipo-particles for claudin-3 overexpressing carcinoma targeting; see entire document, e.g., title, abstract, page 6. Yang et al. teach claudin-3 (also known as CLDN3) is overexpressed in various carcinomas including breast, colorectal, gastric, pancreatic, prostate, and ovarian cancer; see second paragraph on page 2, last paragraph on page 14.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of the references so as to have phospholipid encapsulated gold nanoparticles are conjugated to monoclonal antibodies, wherein the antibody is anti-Claudin3 monoclonal antibody. One would have been motivated to do so because Walker et al. teach phospholipid encapsulated gold nanoparticles are conjugated to monoclonal antibodies; Yang et al. teach an anti-Claudin3 monoclonal antibody embedded lipo-particles for claudin-3 overexpressing carcinoma targeting. Thus, one of ordinary skill in the art would have a reasonable expectation of success that by combining the teachings of the references so as to substitute the antibody of Walker et al. for another antibody (e.g., anti-Claudin3 antibody) of Yang et al., because simple substitution of the antibody of Walker et al. for another antibody (e.g., anti-Claudin3 antibody) of Yang et al. would obtain predictable results.
Given the examination guidelines for determining obviousness under 35 U.S.C. 103 in view of the Supreme Court decision in KSR International Co. V. Teleflex Inc. 82 USPQ2d 1385 (2007) and the Examination Guidelines set forth in the Federal Register (Vol. 72, No. 195, October 10, 2007) and incorporated recently into the MPEP (Revision 9, March 2014), the following rationales to support rejection under 35 U.S.C. 103(a) are noted:
A) Combining prior art elements according known methods to yield predictable results.
B) Simple substitution of one known element for another to obtain predictable results.
C) Use of known technique to improve similar devices (methods, or products) in the same way.
D) Applying known technique to a known device (method, or product) ready for improvement to yield predictable results.
E) “Obvious to try” --- choosing form a finite number of identified, predictable solutions, with a reasonable expectation of success.
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art.
G) Some teachings, suggestion, or motivation in the prior art that would lead to one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
In this case, simple substitution of antibody of Walker et al. for another antibody (e.g., anti-Claudin3 antibody) of Yang et al. would obtain predictable results.
Obviousness is not the result of a rigid formula disassociated from the consideration of the facts of a case. Indeed, the common sense of those skilled in the art demonstrates why some combinations would have been obvious where others would not. See KSR International Co. V. Teleflex Inc. 82 USPQ2d 1385 (2007). From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention.
For claims 5-6, although Walker et al. teach lipids mixed in different ratios (see page 24-lines 3-10), it is noted that generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)., see MPEP 2144.05(II).
For claim 16, the instant claimed SEQ ID NO: 8 is the amino acid sequence of human light chain constant region (see [0110] of Park et al., SEQ ID NO: 20 of Park et al. is 100% identical with the instant claimed SEQ ID NO: 8; see below sequence alignment 1). A cysteine modified human light chain constant region, is well known in the art, which is evidenced by SEQ ID NO: 229 of Shiraiwa et al., SEQ ID NO: 229 of Shiraiwa et al. is 100% identical with the instant claimed SEQ ID NO: 9; see below sequence alignment 2.
Conclusion
21. No claim is allowed.
22. Any inquiry concerning this communication or earlier communications from the examiner should be directed to YAN XIAO whose telephone number is (571)270-3578. The examiner can normally be reached M-F 8-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis can be reached on 571-270-3503. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/YAN XIAO/Primary Examiner, Art Unit 1642
Sequence alignment 1
US-10-159-006-20
Filing date in PALM: 2002-06-03
Sequence 20, US/10159006
Publication No. US20030143229A1
GENERAL INFORMATION
APPLICANT: Park, John E.
APPLICANT: Garin-Chesa, Pilar
APPLICANT: Bamberger, Uwe
APPLICANT: Leger, Olivier
APPLICANT: Saldanha, Jose W.
APPLICANT: Rettig, Wolfgang J.
TITLE OF INVENTION: FAPa-specific Antibody with Improved Producibility
FILE REFERENCE: 0652.1890002
CURRENT APPLICATION NUMBER: US/10/159,006
CURRENT FILING DATE: 2002-06-03
PRIOR APPLICATION NUMBER: US 09/301,593
PRIOR FILING DATE: 1999-04-29
PRIOR APPLICATION NUMBER: EP 98107925.4
PRIOR FILING DATE: 1998-04-30
PRIOR APPLICATION NUMBER: US 60/086,049
PRIOR FILING DATE: 1998-05-18
NUMBER OF SEQ ID NOS: 108
SEQ ID NO 20
LENGTH: 107
TYPE: PRT
ORGANISM: Homo sapiens
Query Match 100.0%; Score 553; Length 107;
Best Local Similarity 100.0%;
Matches 107; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 RTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQD 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 RTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQD 60
Qy 61 SKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC 107
|||||||||||||||||||||||||||||||||||||||||||||||
Db 61 SKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC 107
Sequence alignment 2
US-17-264-388-229
(NOTE: this sequence has 5 duplicates in the database searched.
See complete list at the end of this report)
Sequence 229, US/17264388
Publication No. US20220195045A1
GENERAL INFORMATION
APPLICANT: CHUGAI SEIYAKU KABUSHIKI KAISHA
TITLE OF INVENTION: ANTIGEN-BINDING MOLECULE CONTAINING
TITLE OF INVENTION: TWO ANTIGEN-BINDING DOMAINS THAT ARE
TITLE OF INVENTION: LINKED TO EACH OTHER
FILE REFERENCE: 6663.0165
CURRENT APPLICATION NUMBER: US/17/264,388
CURRENT FILING DATE: 2021-01-29
PRIOR APPLICATION NUMBER: PCT/JP2019/030564
PRIOR FILING DATE: 2019-08-02
PRIOR APPLICATION NUMBER: JP 2018-146929
PRIOR FILING DATE: 2018-08-03
NUMBER OF SEQ ID NOS: 1241
SEQ ID NO 229
LENGTH: 107
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: CL
Query Match 100.0%; Score 557; Length 107;
Best Local Similarity 100.0%;
Matches 107; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 RTVAAPSVFIFPPSDECLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQD 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 RTVAAPSVFIFPPSDECLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQD 60
Qy 61 SKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC 107
|||||||||||||||||||||||||||||||||||||||||||||||
Db 61 SKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC 107