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
Responsive to communications of 6/19/2026
Claims pending 1,3-6,8-16
Claims currently under consideration 1,3-6,8-16
Priority
This application has a filing date of 12/07/2022 and is a 371 of
PCT/JP2022/014255 filed 03/25/2022
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in Japan on 03/26/2021. Receipt is acknowledged of certified copies of document no. 2021-054300 required by 37 CFR
Withdrawn Objection(s) and/or Rejection(s)
The rejection of Claim 11 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph is hereby withdrawn in view of applicant’s amendment
Maintained Claim Rejections - 35 USC § 102
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.
Claims 1,3-5,11,13,15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Heydari et al (2007 Journal of Biomedical Materials Research Part A 83(4):906-914; doi: 10.1002/jbm.a.31368).
Heydari et al teach, throughout the document and especially the abstract, modification of a substrate with photoreactive gelatin for attaching cells (e.g. COS7). More particularly, such as disclosed on p 908 plus figures 2,6,7 and/or 8, Heydari prepares a substrate that has a surface to which a cell is to be immobilized and on which a layer of a substance immobilizing agent is formed. The substrate comprises:
said substance immobilizing agent has photoreactive groups and contains a water-soluble polymer or else a water-soluble monomer (amino acids) which turn into the water-soluble polymer by polymerization; a thickness of the layer of the substance immobilizing agent is not less than 3 nm and less than 500 nm;a contact angle with water of the surface of the substrate, to which surface the substance is to be immobilized, is not less than 20° and less than 80°; and the water-soluble polymer is a water-soluble naturally occurring polymer derivative which has, in one collagen molecule thereof at least two photoreactive groups. The foregoing reads on claims 1B, 3,4,5,11,13 & 15 (aromatic azide groups).
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Please note that the above rejection has been updated from the original version to more clearly address Applicant’s arguments.
Response to Arguments
The remarks accompanying the present response argue that not all elements are taught.
Applicant’s arguments have been fully considered but they are not deemed persuasive for the following reasons.
More particularly in the pertinent section starting at p 7, the remarks assert Heydari et al do not teach a substrate with a 20 to 80 degree contact angle; and that Heydari is drawn to culturing cells rather than immobilizing substances like nucleic acids, proteins or allergens.
With regard to a substrate with a 20-80 degree contact angle, Applicant’s attention is respectfully invited to figure 2 bars 1-6 and 10-12 that each have a water contact angle between 20 and 80 degrees.
With regard to cells vs substances, the examiner submits Heydari’s COS7 cells constitute substances that adhere to photo reactive gelatin necessarily through components of said cells. Such adhesion is demonstrated in figure 8.
Thus, in response to applicant's argument that the references fail to show certain features of applicant’s invention, it is noted that the features upon which applicant relies (i.e., nucleic acids, proteins or allergens) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Maintained Claim Rejections - 35 USC § 103
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, 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.
Claims 1,3-5,11,13,15 and 1A,6,8,9,10,12,14,16 are rejected under 35 U.S.C. 103 as being unpatentable over Heydari et al (2007 Journal of Biomedical Materials Research Part A 83(4):906-914; doi: 10.1002/jbm.a.31368) in view of Sivakumar et al (2013 PLOS One vol 8 issue 12 e81726).
Heydari et a is relied on as above regarding claims 1B,3-5,11,13,15.
Heydari et al do not explicitly teach: a synthetic polymer in a spot-like shape with at least two photoreactive groups in an amount not less than 2.5 mol percent and less than 50 mol %, that is electrically neutral and is for antibody/allergen sample testing per claims 1A,6c,8,9,10.16; the technique of claim 12; nor a structure of claim 14.
As in claims 1A,6c,8,9,10,16; the technique of claim 12; and claim 14(i) when R1 is an aromatic azide R12 is a single bond and R2 is a PEG (polyethylene glycol, a polyoxyalkylene); and 16, Sivakumar et al suggest throughout the document and especially the first page and figures 1, 3 and 7, a synthetic polymer with least two photoreactive groups in an amount not less than 2.5 mol percent and less than 50 mol %, that is electrically neutral and is for antibody/allergen sample testing in a spot-like shape.
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have used the chemistry of Sivakumar et al for the cell substrate of Heydari et al.
One of ordinary skill in the art would have been motivated to have used the chemistry of Sivakumar et al for the cell substrate of Heydari et al and had a reasonable expectation of success in doing so in light of the excellent diagnostic sensitivity results reported by Sivakumar et al in table 4 and moreover, in the second paragraph of the Discussion section at p 8, Sivakumar et al note photoreactive PEG has been shown to be a stable, uniform, suitable for miniaturization, and appropriate for photo-immobilization studies of both cells and proteins.
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Please note that the above rejection has been updated from the original version to more clearly address Applicant’s newly amended claims and/or arguments.
Response to Arguments
The remarks accompanying the present response argue: (i) not all elements are taught; and (ii) motivation is lacking.
Applicant’s arguments have been fully considered but they are not deemed persuasive for the following reasons.
Concerning (i), Applicant does not offer further arguments regarding the above obviousness rejection(s) beyond what was set forth with regard to the 35 U.S.C. § 102 rejection, above. To the extent that Applicant is merely repeating their previous argument, the examiner respectfully submits that those issues were adequately addressed in the above section(s), which is/are incorporated in their entirety(ies) herein by reference.
More particularly regarding (ii), the first full paragraph a p 8 of the current remarks contends the skilled artisan would not be motivated to combine Heydari et al and Sivakumar et al because they are in different fields.
In response to applicant's argument that Sivakumar et al is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, it is noted Sivakumar et al plainly indicate in the second full paragraph at p 8 that photoreactive PEG is well suited for immobilizing cells (and proteins) and indeed not all cell types are adherent like COS7 – providing even further motivation to combine beyond the benefits of sensitivity, stability, uniformity and suitability for miniaturization. As such, Sivakumar et al is clearly in the same field as the present invention and is at least reasonably pertinent toward the interest of the Heydari.
New Claim Rejection(s) – 35 USC § 112
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.
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.
Claims 14 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 rejection concerns new matter.
Claim 14 has been each been changed to introduce new formulas (5), (6) and (7) and remove the definition of R1 “in each of formulae (1) and (3)” and R2 “in each of formulae (2) and (4), whereas section III of the current remarks in urges support therefor may be found in paragraph 0044 and the examples section in the English specification as originally filed. In reviewing such passages, however, the examiner, at best, only finds description PEG polymers bearing azidophenyl monomers structures (7) and (8) illustrated therein paragraph 0044, as opposed to the considerably broader Markush groups (5) -(7) now recited in amended claim 14.
Accordingly, the specification as originally filed provided no implicit or explicit support for such new material and the current response does not point to where support may be found in the priority documents.
Applicants are reminded that it is their burden to show where the specification supports any amendments to the disclosure. See MPEP 714.02, paragraph 5, last sentence and also MPEP 2163.06 I.
MPEP 2163.06 notes “If new matter is added to the claims, the examiner should reject the claims under 35 U.S.C. 112, first paragraph - written description requirement. In re Rasmussen, 650 F.2d 1212, 211 USPQ 323 (CCPA 1981).” MPEP 2163.02 teaches that “Whenever the issue arises, the fundamental factual inquiry is whether a claim defines an invention that is clearly conveyed to those skilled in the art at the time the application was filed...If a claim is amended to include subject matter, limitations, or terminology not present in the application as filed, involving a departure from, addition to, or deletion from the disclosure of the application as filed, the examiner should conclude that the claimed subject matter is not described in that application. MPEP 2163.06 further notes “When an amendment is filed in reply to an objection or rejection based on 35 U.S.C. 112, first paragraph, a study of the entire application is often necessary to determine whether or not “new matter” is involved. Applicant should therefore specifically point out the support for any amendments made to the disclosure.
New Claim Rejections - 35 USC § 112
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.
Claims 11 and 13 is 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 11 recites the limitation "the substrate" in line 2. There is insufficient antecedent basis for this limitation in the claim, rendering the metes and bounds uncertain.
Claim 13 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential structural cooperative relationships of elements, such omission amounting to a gap between the necessary structural connections. See MPEP § 2172.01. The omitted structural cooperative relationships which render the metes and bounds uncertain are as follows.
Claim 13 recites formulas (5),(6) and (7) which contradict the definitions thereof set forth in paragraphs 0048 and 0062 of the present published application, making what the claim intends to encompass uncertain.
In accordance with MPEP 2173.02: If the language of the claim is such that a person of ordinary skill in the art could not interpret the metes and bounds of the claim so as to understand how to avoid infringement, a rejection of the claim under 35 U.S.C. 112, second paragraph, would be appropriate. See Morton Int ’l, Inc. v. Cardinal Chem. Co., 5 F.3d 1464, 1470, 28 USPQ2d 1190, 1195 (Fed. Cir. 1993).
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.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER M GROSS whose telephone number is (571)272-4446. The examiner can normally be reached M-F 10-6.
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, Heather Calamita can be reached on (571)272-2876. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTOPHER M GROSS/
Primary Examiner, Art Unit 1684
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