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 .
Claims 2 and 7-8 are cancelled.
Claim 1 is currently amended.
Claims 1, 3-6, and 9-16 are pending and under examination on the merits.
Priority
This application is a 371 of PCT/JP2022/020043, filed 05/12/2022, which claims priority to JAPAN 2021-095160, filed 06/07/2021. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Withdrawn Objections/Rejections
All objections/rejections of claim 2 are withdrawn in response to cancellation of the claim by the 07/08/2026 claim amendments. Upon further consideration of the state of the art, the rejection of the claims for lack of written description of the genera of polyfunctional linkers and dye-trapping material under 35 USC §112(a) are withdrawn.
Maintained-Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
The factual inquiries 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 3-6 and 9-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Genentech (US 2020/0292536 A1).
Regarding claim 1, note the expansive descriptions and lack of a closed definition of:
Control substance (see for example, pages 13-15 of the specification);
Dye trapping material (see for example, pages 15-18)
Chemical crosslinking agent, polymerization initiator, and ionic additive (see for example, pages 18-20); and
Polyfunctional linker molecule (for example, pages 20-21).
Note further that the recited intention that the slide is for pathological examination is not given patentable weight as it fails to breathe life and meaning into the claim. Therefore, where the prior art teaches a slide having the recited structural components, the claim may be anticipated/made obvious.
Genentech teaches a glass slide for IHC (see for example, paragraph 0083) to which a solid antigen/carrier protein gel is affixed, said solid antigen/carrier protein gel (hereinafter ‘gel’) comprising a purified antigen and a carrier protein (where the carrier protein may be selected from an albumin protein (e.g., a serum albumin protein), an egg white protein or a mixture of egg white proteins, gelatin, and poly-lysine)(see for example paragraph 0073). Genentech teaches that the term “antigen” therein is used in the broadest sense and encompasses various forms of both polypeptide and non-polypeptide antigens, including, without limitation, small peptide antigens, full-length protein antigens, carbohydrate antigens, lipid antigens, and nucleic acid antigens (see for example, paragraph 0069). The process of ‘affixing’ the solid antigen/carrier protein gel to the slide is not explicitly taught, but the artisan would have understood using a common fixative, such as the fixatives taught by Genentech (where the fixative may comprise glutaraldehyde, Davidson's fixative, Bouin's fixative, ½ strength Karnovski's fixative, or a zinc salt (see for example, paragraph 0012) would be a predictable means, particularly given the consistent description of attaching the gel to the slide as a process of ‘affixing’. The gel may have been fixed in a fixative (see for example, claims 40-41). Where the fixative, such as glutaraldehyde, is used to fix the gel and to affix the gel to the glass slide for IHC, this teaching is deemed to read on and make obvious the recitation that the control substance (antigen) is fixed onto the glass slide with a polyfunctional linker (there being nothing to structurally distinguish the glutaraldehyde of Genentech from the instantly recited glutaraldehyde acting as a polyfunctional linker). Where the gel or antigen/carrier mixture is deposited on the slide, this is presumed to read upon formation of a control spot in the absence of a preclusive definition. Note that while the carrier protein is not called a dye trapping material, there is no structural distinction between the instantly claimed dye trapping material and the carrier protein of Genentech, therefore the intended use (that the material traps dye) is presumed to be present in the slide of Genentech and is insufficient to secure patentability absent a showing of surprising results (which is not apparent from the instant disclosure).
It would have been prima facie obvious to the person of ordinary skill in the art to arrive at the claimed invention from the disclosure of the cited reference. The artisan would have been motivated to make and use the invention as claimed to as a synthetic control useful in IHC (see for example, the abstract). The artisan would have had a reasonable expectation of success based on the cumulative disclosure of this prior art reference. While glutaraldehyde is not called a polyfunctional linker and the carrier protein is not disclosed as a dye trapping material, the claimed glutaraldehyde and carrier protein would have been presumed by the artisan to perform the implied functions, as claimed, because there is nothing to structurally distinguish the components of Genentech and the components of the instant claims. Applicant is advised that the MPEP provides that:
"[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). In In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed. Cir. 2004), the court held that the claimed promoter sequence obtained by sequencing a prior art plasmid that was not previously sequenced was anticipated by the prior art plasmid which necessarily possessed the same DNA sequence as the claimed oligonucleotides. The court stated that "just as the discovery of properties of a known material does not make it novel, the identification and characterization of a prior art material also does not make it novel." Id. See also MPEP 2112(I) with regard to inherency and product-by-process claims and MPEP § 2141.02 with regard to inherency and rejections under 35 U.S.C. 103,”
(see MPEP 2112(I)). Therefore, the cited reference and teachings are held to make obvious before the filing date, a slide encompassed by and reading on the instant claim 1. The difference between Genentech’s disclosure and that of the instant claims is that Genentech does not teach all of the limitations of the claim in a manner consistent with anticipation, i.e. that the carrier protein is a dye trapping material of that the fixative is acting as a polyfunctional linker. However, as discussed above, the cited teachings of Genentech are deemed to make obvious the limitations of instant claim 1.
Regarding claims 3-4, as discussed above, Genentech teaches that the dye trapping material (carrier protein) may be albumin, gelatin, or poly-l-lysine (all of which are disclosed to be exemplary amino acid polymers; see for example paragraph 0073 of Genentech and instant claims 3-4). The gelatin or albumin of Genentech are understood to read upon the instantly recited dye trapping material (a material capable of trapping dye) because the instant specification discloses that the dye trapping material may be an amino acid polymer which may be gelatin or albumin (see for example, page 40 at paragraph 105 of the specification). Where the gelatin and/or albumin of Genentech are used the same way and appear structurally indistinct, they are presumed to be capable of trapping dye as required by the instant claims.
Regarding claims 5-6 and 9, note that there is no closed, preclusive definition of a control spot provided. Therefore, the gel of Genentech deposited on the glass slide for IHC is deemed to read upon a recited control spot. Genentech teaches that the gel is deposited in a spot, in a test example, sections of BCL2 peptide, occupied an area of 150µm2 or had a diameter of 1mm2 with a 4 µm thickness (see for example, paragraphs 0044, 0053, 0063, 0097, 0157, 0189 and claim 6), either of which are presumed to be acceptable be the size of the gel spots. Alternatively, where Genentech teaches that the get spots on the slide are of a compatible thickness, the artisan would have found it obvious to use the 150 microns-squared or 3.14mm2 (calculated by π x (12)) size for the control spots because Genentech does not teach another size of gel/control spot making both size obvious to the artisan to use with a reasonable expectation of success.
Regarding claim 10, Genentech teaches that a first and second gel (comprising wither different antigens or different concentrations of antigen) may be used in a tissue microarray (TMA) (see for example, paragraphs 0017-0019) and contemplates a third gel being included, the third gel not comprising antigen (see for example, paragraphs 0022-0023) said gels being affixed to a solid substrate (such as a glass slide) (therefore meeting the limitation of a plurality of control spots).
Regarding claim 11, as discussed above, Genentech teaches that the gel is deposited in a spot, in a test example, sections of BCL2 peptide, occupied an area of 150µm2 by 4µm thick (see for example, paragraph 0189 and claim 6). This is presumed to be the size of the gel spots. Alternatively, where Genentech teaches that the get spots on the slide are of a compatible thickness, the artisan would have found it obvious to use the 150 microns-squared size for the control spots because Genentech does not teach another size of gel/control spot.
Regarding claim 12, note that there is no preclusive or closed definition for how a control substance is labeled (see for example, paragraph 0067 of the specification at page 26). Therefore, the teaching of Genentech where the antigen in the antigen/carrier protein gel is fluorescently labeled by detecting a fluorescently labeled secondary antibody bound to a primary antibody bound to the antigen in gel is deemed to read upon an make obvious the limitations of instant claim 12 (where direct detection (use of a fluorescently labeled primary) would have been an obvious alternative to the indirect detection taught by Genentech), noting that once the antibody/antibodies are contacted with the gel/control spot, the gel/control spot comprises the antibody/antibodies meeting the instant claim limitations as drafted (see for example, paragraph 0015-0018, 0020-0022, and 0202). Inclusion of a fluorescent label allows for confirmation that the control substance is localized within the control spot prior to staining, which that artisan would have desired to confirm in order to use the spots as one or more validated experimental controls, with an reasonable expectation of success.
Regarding claim 13, the only definition of the terms ‘porous’, ‘swollen gel’, and ‘xeroform’ are at paragraph 0064 of the specification at page 25. There, the disclosure states that “[e]xamples of the method of making the control spot porous include a method…including a dehydration step with ethanol”. Where no other step or reagent is provided, the artisan would have understood this disclosure to mean that the spot id produced by a method such as one of the disclosed methods or a method of the prior art, where dehydration with ethanol makes the spot porous as instantly recited in claim 13. Genentech teaches that the methods of its disclosure include dehydrating the solid antigen/carrier protein gel. Compounds suitable for dehydrating are known in the art and can include, e.g., alcohols such as ethanol or methanol (see for example, paragraph 0089).
Regarding claim 14, it is noted that the claim does not include recitation of adding/using/making the polyfunctional linker. This is deemed permissible because the claim is drafted using open, ‘comprising’ language. Note that ‘forming’ is not defined throughout the disclosure and there is not explicitly required step(s) or sequence/timing thereof. Therefore, prior teaching a method of making where a mixture of a control substance (antigen) and dye trapping material (carrier protein) is made and where a control spot is eventually formed on a glass slide is deemed to make obvious the claimed method. Genentech teaches a method for generating a solid antigen/carrier protein gel for immunohistochemical (IHC) staining, the method comprising mixing a purified antigen with a liquid solution comprising a carrier protein selected from the group consisting of an albumin protein, an egg white protein or mixture of egg white proteins, and gelatin to produce an antigen/carrier protein liquid solution (held to read on the instantly claimed mixture step) (see claim 1) and heating the mixture to form a solid antigen/carrier gel where the gel is then affixed to a solid substrate (see claim 40), where the solid substrate may be a glass slide for IHC (see for example, paragraph 0083).
Regarding claim 15, Genentech teaches preparing the antigen/carrier gel in a microcentrifuge tube (substantially tube-shaped such that any difference between the shape of the gel of Genentech and the instantly claimed shape would have been presumed an obvious variation unlikely to impact the overall performance of the gel for IHC) (see for example, paragraphs 0117, 0120, 123, 0136, 0155, and figures 2A-2c). Genentech then teaches that the tube of gel may be sectioned using a microtome (see for example, paragraphs 0117 and 0123 and figures 2B-2C). Where Genentech teaches a desired gel thickness to affix to a substrate, such as a glass slide, the artisan would have found it obvious to use the microtome to section the gel into a corresponding thickness prior to affixing the gel to the slide, thereby forming the control spot on the slide as instantly recited (see for example, paragraphs 0083 and 0189 and claims 6 and 40). Therefore, the teachings of Genentech make obvious the instantly claimed methods of claims 14 and 15.
Regarding claim 16, as discussed above, Genentech teaches a method of applying the antigen/control substance and carrier/dye trapping material concurrently in the form of a pre-mixed gel to a glass slide. While this is not the same ordering of application to the slide as instantly recited, the method of Genentech is deemed to make obvious the instantly claimed method. The MPEP provides that:
“Ex parte Rubin, 128 USPQ 440 (Bd. App. 1959) (Prior art reference disclosing a process of making a laminated sheet wherein a base sheet is first coated with a metallic film and thereafter impregnated with a thermosetting material was held to render prima facie obvious claims directed to a process of making a laminated sheet by reversing the order of the prior art process steps.). See also In reBurhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946) (selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results); In reGibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930) (Selection of any order of mixing ingredients is prima facie obvious.),”
(see MPEP §2144.04(IV)(C)). Here, there is no showing of a surprising result or criticality of application step sequence. Therefore Genentech is deemed to have made obvious to the artisan the instantly recited method of making the slide as an obvious variation of steps, where the variation would have been expected to predictably yield a functional slide of Genentech which is a functional slide of the instantly claimed method.
Maintained-Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1, 3-6 and 9-11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of copending Application No. 19/129,049 (‘049).
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims pertain to a slide having substantially the same elements.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding claims 1, 3-4, and 10, ‘049 claims a slide (presumed to be a glass slide because all mentions of a slide in the ‘049 specification either state that the slide is made of glass or are consistent with a slide being made of glass) comprising a control spot having no antigen (negative control), a spot having fixation agent and no antigen, and a spot having antigen and fixation agent (see for example claim 1; noting that the specification of ‘049 only describes/defines the fixation agent as an aldehyde at paragraph 0021) where the aldehyde is specified to be glutaraldehyde or formaldehyde in claim 6 of ‘049 where the spots have an amine-containing polymer, which may be albumin, gelatin, or collagen (see for example, claims 7-9). ‘049 claims that the antigen in the spot may be a protein selected from a closed group (see for example, claim 14 of ‘049).Where the 3 disclosed spots (as well as the potentially additional spots having different antigen concentrations) reads upon the recited plurality of spots (see ‘049 claims 1-2, for example).
It would have been prima facie obvious to the person of ordinary skill in the art to arrive at the claimed invention from the disclosure of ‘049. The artisan would have been motivated to make and use the invention as claimed by ‘049 for accuracy (see the preamble of claim 1 of ‘049). The artisan would have had a reasonable expectation of success based on the cumulative disclosure of this copending reference. The difference between ‘049 and that of the instant claims is that ‘049 does not teach all of the limitations of the claim in a manner consistent with anticipation, i.e. to the terminology is different, the fixation agent is no disclosed to be a polyfunctional linker and the amine-containing polymer is not disclosed to trap dye, however there is nothing to distinguish the prior art products/structures from those instantly claimed and, because function flows from structure, the functions are presumed to be present where discovery or an unappreciated property is insufficient to lend patentability.
Regarding claim 5, ‘049 claims that the spot has an area of 1mm2-1000mm2 (see for example, claim 15 of ‘049).
Regarding claims 6, 9, and 11, ‘049 claims that the spot has a thickness of 0.5µm-500µm (see for example, claim 16 of ‘049).
Claim 12-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of copending Application No. 19/129,049 (‘049), as applied to claims 1, 3-6 and 9-11 above, in view of Genentech (US 2020/0292536 A1).
Regarding claim, 12, note that there is no preclusive or closed definition for how a control substance is labeled (see for example, paragraph 0067 of the instant specification at page 26). ‘049 claims a slide meeting the limitations of instant claim 1, as discussed above, and further claims that the spot(s) may contain a primary antibody that binds to a secondary antibody with an enzyme for colorimetric detection, but does not state explicitly that the antibody is fluorescent.
However, Genentech teaches that the antigen in the antigen/carrier protein gel is fluorescently labeled by detecting a fluorescently labeled secondary antibody bound to a primary antibody bound to the antigen in gel. This teaching is deemed to read upon an make obvious the limitations of instant claim 12 (where direct detection (use of a fluorescently labeled primary) would have been an obvious alternative to the indirect detection taught by Genentech), noting that once the antibody/antibodies are contacted with the gel/control spot, the gel/control spot comprises the antibody/antibodies meeting the instant claim limitations as drafted (see for example, paragraph 0015-0018, 0020-0022, and 0202). Inclusion of a fluorescent label allows for confirmation that the control substance is localized within the control spot prior to staining, which that artisan would have desired to confirm in order to use the spots as one or more validated experimental controls, with an reasonable expectation of success.
Regarding claim 13, the only definition of the terms ‘porous’, ‘swollen gel’, and ‘xeroform’ are at paragraph 0064 of the specification at page 25. There, the disclosure states that “[e]xamples of the method of making the control spot porous include a method…including a dehydration step with ethanol”. Where no other step or reagent is provided, the artisan would have understood this disclosure to mean that the spot id produced by a method such as one of the disclosed methods or a method of the prior art, where dehydration with ethanol makes the spot porous as instantly recited in claim 13. Genentech teaches that the methods of its disclosure include dehydrating the solid antigen/carrier protein gel. Compounds suitable for dehydrating are known in the art and can include, e.g., alcohols such as ethanol or methanol (see for example, paragraph 0089).
Regarding claim 14, it is noted that the claim does not include recitation of adding/using/making the polyfunctional linker. This is deemed permissible because the claim is drafted using open, ‘comprising’ language. Note that ‘forming’ is not defined throughout the disclosure and there is not explicitly required step(s) or sequence/timing thereof. Therefore, prior teaching a method of making where the a mixture of a control substance (antigen) and dye trapping material (carrier protein) is made and where a control spot is eventually formed on a glass slide is deemed to make obvious the claimed method. Genentech teaches a method for generating a solid antigen/carrier protein gel for immunohistochemical (IHC) staining, the method comprising mixing a purified antigen with a liquid solution comprising a carrier protein selected from the group consisting of an albumin protein, an egg white protein or mixture of egg white proteins, and gelatin to produce an antigen/carrier protein liquid solution (held to read on the instantly claimed mixture step) (see claim 1) and heating the mixture to form a solid antigen/carrier gel where the gel is then affixed to a solid substrate (see claim 40), where the solid substrate may be a glass slide for IHC (see for example, paragraph 0083).
Regarding claim 15, Genentech teaches preparing the antigen/carrier gel in a microcentrifuge tube (substantially tube-shaped such that any difference between the shape of the gel of Genentech and the instantly claimed shape would have been presumed an obvious variation unlikely to impact the overall performance of the gel for IHC) (see for example, paragraphs 0117, 0120, 123, 0136, 0155, and figures 2A-2c). Genentech then teaches that the tube of gel may be sectioned using a microtome (see for example, paragraphs 0117 and 0123 and figures 2B-2C). Where Genentech teaches a desired gel thickness to affix to a substrate, such as a glass slide, the artisan would have found it obvious to use the microtome to section the gel into a corresponding thickness prior to affixing the gel to the slide, thereby forming the control spot on the slide as instantly recited (see for example, paragraphs 0083 and 0189 and claims 6 and 40). Therefore, the teachings of Genentech make obvious the instantly claimed methods of claims 14 and 15.
Regarding claim 16, as discussed above, Genentech teaches a method of applying the antigen/control substance and carrier/dye trapping material concurrently in the form of a pre-mixed gel to a glass slide. While this is not the same ordering of application to the slide as instantly recited, the method of Genentech is deemed to make obvious the instantly claimed method. The MPEP provides that:
“Ex parte Rubin, 128 USPQ 440 (Bd. App. 1959) (Prior art reference disclosing a process of making a laminated sheet wherein a base sheet is first coated with a metallic film and thereafter impregnated with a thermosetting material was held to render prima facie obvious claims directed to a process of making a laminated sheet by reversing the order of the prior art process steps.). See also In reBurhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946) (selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results); In reGibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930) (Selection of any order of mixing ingredients is prima facie obvious.),”
(see MPEP §2144.04(IV)(C)). Here, there is no showing of a surprising result or criticality of application step sequence. Therefore Genentech is deemed to have made obvious to the artisan the instantly recited method of making the slide as an obvious variation of steps, where the variation would have been expected to predictably yield a functional slide of Genentech which is a functional slide of the instantly claimed method.
Applicant’s Arguments and Responses
A. Applicant argues for withdrawal of the rejections under 35 USC §103 and for withdrawal of the rejections for double patenting of claims 12-16 which rely upon Genentech (see for example, pages 7-9 of the 07/08/2026 remarks).
Response: There is zero structural distinction between the carrier protein (where the carrier protein may be selected from an albumin protein (e.g., a serum albumin protein), an egg white protein or a mixture of egg white proteins, gelatin, and poly-lysine)(see for example paragraph 0073) of Genentech and the instantly recited dye trapping material which contains at least one material selected from an amino acid polymer, wherein the amino acid polymer contains at least one polymer selected from gelatin, collagen, albumin, polyglutamic acid, and polylysine (see instant claims 1 and 3-4). Where the end result of the slide is claims, the process by which the slide is made is not weighed in the determination of patentability absent an evidenced, convincing showing that the claim slide functions differently or has some unexpected, different quality in comparison to the prior art slide. No such evidenced, convincing showing has been considered. Considering this argument for the method claims 14-16, it is noted that claims 14-15 are the prior art method which Applicant attempts to distance the claims from and over. Just as in Genentech, Applicant claims a method for producing the slide by first mixing the control substance (antigen) and carrier protein/dye-trapping material of and then forming a control spot containing the mixture on a glass slide (presumably via affixing the mixture to the glass slide by a fixative/polyfunctional linker, noting that the fixative of Genentech, being glutaraldehyde (see for example, paragraph 0012), is structurally indistinct from the claimed polyfunctional linker which may be glutaraldehyde. Applicant suggests that the slide of Genentech would not have been understood by the artisan to be compatible for IHC. This is unfounded as the slide of Genentech is disclosed to be for IHC (see for example, the abstract and claim 1 of Genentech). Where the prior art method for producing the slide reads on the claimed a claimed method for making the slide, it is inconceivable that the slide produced by the method would somehow be appreciably different where the reagents employed are structurally indistinct. Further, where Genentech discloses the slide for IHC, Applicant bears the burden of providing an evidenced showing for why the prior art, presumed to be enabled (see MPEP §2121(I)), would not function as disclosed and claimed. Applicant has not made such an evidenced showing. Regarding Applicant’s arguments in relation to instant claim 16, Applicant has not shown any critical or surprising property obtained by practicing the method of instant claim 16 compared to practicing the method of Genentech and has not made an evidenced, persuasive argument that the method of claim 16 is nonobvious over the method of Genentech. The arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965); In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997). See MPEP 2145 (I). Therefore, the rejections for nonobviousness and the double patenting rejections over Genentech are maintained at this time.
The arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965); In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997). See MPEP 2145 (I).
C. Applicant requests that the rejections for double patenting be held in abeyance (see for example, page 9 of the 07/08/2026 remarks).
Response: This has been fully considered but is not found to be persuasive. Applicant’s attention is respectfully directed to M.P.E.P. § 804(I)(B)(1), which states: “A complete response to a nonstatutory double patenting (NSDP) rejection is either a reply by applicant showing that the claims subject to the rejection are patentably distinct from the reference claims or the filing of a terminal disclaimer in accordance with 37 CFR 1.321 in the pending application(s) with a reply to the Office action (see MPEP § 1490 for a discussion of terminal disclaimers). Such a response is required even when the nonstatutory double patenting rejection is provisional.” “As filing a terminal disclaimer, or filing a showing that the claims subject to the rejection are patentably distinct from the reference application’s claims, is necessary for further consideration of the rejection of the claims, such a filing should not be held in abeyance. Only objections or requirements as to form not necessary for further consideration of the claims may be held in abeyance until allowable subject matter is indicated. Replies with an omission should be treated as provided in MPEP § 714.03.Therefore, an application must not be allowed unless the required compliant terminal disclaimer(s) is/are filed and/or the withdrawal of the nonstatutory double patenting rejection(s) is made of record by the examiner.” See MPEP § 804.02, subsection VI, for filing terminal disclaimers required to overcome nonstatutory double patenting rejections in applications filed on or after June 8, 1995. (emphasis added). Accordingly, the rejection is maintained and is expressly not held in abeyance.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Yamaguchi et al (J Vis Exp. 2018 Jan 17;(131):56235. doi: 10.3791/56235) teach preparing serial ultrathin sections of microorganism for TEM (see reference in its entirety).
Konica (JP 2014235081 A) teaches an immunostaining method for detecting an antigen in a pathological tissue fixed on the surface of a base glass treated with an amino-containing silane coupling agent by immunostaining using fluorescent nanoparticles, (I) a step of adding a blocking agent to the pathological tissue fixed on the surface of the base glass treated with the amino-containing silane coupling agent (see entire reference, with claim 1 being exemplary).(II) adding an antibody that reacts with the antigen to the pathological tissue.
Zaaba, E. and Schram, V. teach that coating a slide in gelatin for IHC is well known in the art (with a dehydration in ethanol step; see references in their entirety).
Koh et al (STAR Protoc. 2020 Dec 8;1(3):100203. doi: 10.1016/j.xpro.2020.100203) teach embedding sample into collagen on slide for IHC (see reference in its entirety).
Nicholas et al (Methods Mol Biol. 2014;1136:137-69. doi: 10.1007/978-1-4939-0329-0_9) teach a microtubule (MT)-surface coupling protocol in which aminosilanized glass is formylated using the cross-linker glutaraldehyde, fluorescence-labeled MTs are covalently attached, and the surface is passivated with highly pure beta-casein. The technique presented here yields rigid MT immobilization while simultaneously blocking the remaining glass surface against nonspecific binding by polystyrene optical trapping microspheres. This surface chemistry is straightforward and relatively cheap and uses a minimum of specialized equipment or hazardous reagents (see reference in its entirety with the abstract being exemplary).
Syga et al (Sci Rep 8, 13789 (2018). https://doi.org/10.1038/s41598-018-32166-y)teach a method of immobilizing living and synthetic cells using APTES-glutaraldehyde and teach that the APTES-glutaraldehyde is a generic method of immobilization that should work with any cell or synthetic system that has primary amines on the surface (see reference in its entirety with the abstract being exemplary).
WO 2016143717 A1 (as cited on the 11/10/2023 IDS) teaches a carrier (slide) using silane coupling to attach substance, the carrier then being coated in BSA (see reference in its entirety).
US 4931386 A, IL 74774 A, and CN 103116018 A are also deemed relevant to the state of the art to which the claims are directed.
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/Ashley Gao/
Examiner, Art Unit 1678
/GREGORY S EMCH/Supervisory Patent Examiner, Art Unit 1678
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