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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-10 in the reply filed on November 17th, 2025 is acknowledged.
Claims 11 and 12 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on November 17th, 2025.
It is also noted by the Examiner that the Applicant has renumbered the claims to correct a clerical misnumbering in the originally filed claims. The claim numbers above reference the renumbered claims from the claim listing filed November 17th, 2025.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on May 21st, 2025 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Claim Summary
Claims 1 and 2 have been amended. Claim 5 has been canceled. Claims 1-4 and 6-12 are pending. Claims 11 and 12 are withdrawn from consideration as being drawn to a non-elected invention/species. Claims 1-4 and 6-10 are under examination and discussed in this Office action.
Drawings
The drawings are objected to because, while indicated to be Figure 5(B) in the specification, the drawing between Figures 5(A) and 5(C) is labeled as Figure 6(B). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The use of terms like Alexa Fluor, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claim 2 is objected to because of the following informalities:
Claim 2 is missing a period at the end of the claim which should be added.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
The claims contain the following limitations:
Claim 1 recites “a means for detecting the specific binding of the reagent to the HERV antigens, HERV-associated antibodies, or HERV targets”.
Claim 8 recites “wherein the means for detecting the specific binding of the reagent increases the signal amplification and sensitivity”.
Thus, the cited limitation is drawn to a generic means plus function. However, this limitation is not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because a review of the specification yields no limiting definition of the generically claimed means.
If applicant intends to have this limitation interpreted under 35 U.S.C. 112(f) or
pre-AIA 35 U.S.C. 112, sixth paragraph, applicant should indicate where in the
specification the specific structure is indicated.
Claim Rejections - 35 USC § 112(b)
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 4, 6, and 9 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 4 recites the limitation “wherein the HERV-associated antibodies are the subject’s autoantibodies”. As is generally known to one of ordinary skill in the art, autoantibodies are produced by a subject’s own immune system as a defense mechanism against foreign molecules. This information is supported by the Applicant’s own specification (see paragraph [0008]). Therefore, it is unclear from this recitation how it is possible for what is presumably a broadly applicable kit for HERV detection to contain a reagent capable of specifically binding to HERV-associated autoantibodies produced by a particular subject. If this is indeed the intended interpretation, the kit would only be useful for a specific subject and it is unclear how it could more widely be applied to a variety of subjects.
Claim 6 recites the limitation "wherein the HERV target is detected by RT-PCR". There is insufficient antecedent basis for this limitation in the claim. Claim 1, from which claim 6 depends, introduces HERV targets, indicating a plurality of targets, not a single target as recited in claim 6.
Regarding claim 9, the two instances of the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the two instances of the phrase are part of the claimed invention. See MPEP § 2173.05(d). For the purpose of compact prosecution, any limitations following the two instances of the phrase “such as” are interpreted to not be required by the claim.
Claim 9 also contains the trademark/trade name Alexa Fluor. 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 is used to identify/describe fluorescent dyes from the trademarked line of dyes Alexa Fluor and, accordingly, the identification/description is indefinite.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Scope of Enablement
Claims 1-4 and 6-10 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, for issues related to scope of enablement. With regards to claims 1-4 and 6-10, the specification, while being enabling for a human subject, does not reasonably provide enablement for any subject as embraced by the claims. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue.” See MPEP § 2164. These factors include, but are not limited to: the breadth of the claims, the nature of the invention, the state of the prior art, the level of one of ordinary skill, the level of predictability in the art, the amount of direction provided by the inventor, the existence of working examples, the quantity of experimentation needed to make or use the invention based on the content of the disclosure.
The office has analyzed the specification in direct accordance to the factors outlines in In re Wands. MPEP 2164.04 states: “[W]hile the analysis and conclusion of a lack of enablement are based on factors discussed in MPEP 2164.01(a) and the evidence as whole, it is not necessary to discuss each factor in written enablement rejection.” These factors will be analyzed, in turn, to demonstrate that one of ordinary skill in the art would have had to perform “undue experimentation” to make and/or use the invention and therefore, applicant’s claims are not enabled.
(A) With respect to the breadth of the claims: Claim 1 as currently drafted encompasses an assay kit for detecting HERV-associated cancer biomarkers in a subject. “A subject” and “the subject” does not limit the subject to a human subject as described in the specification. Consequently, the breadth of the claims is expansive since they encompass any kind of non-human subject. This can include subjects such as dogs, cats, and birds, among many other examples. Claims 2-4 and 6-10 encompass the same breadth as claim 1 since they do not limit the subject to a human subject.
(B) The nature of the invention: The invention is in the field of a kit for detecting HERV-associated cancer biomarkers.
(C), (D), (E) With respect to the state of the prior art, the level of one of ordinary skill and predictability of the art: Juppner (Functional properties of the PTH/PTHrP receptor, Bone, August 1995, S39-S42) teaches that despite significant structural conservation, rat, opossum, and human PTH/PTHrP receptor homologs display distinct functional characteristics (Abstract; Pages 39S-40S). This art indicates that there is known functional differences between homologs in different organisms, and therefore inter-species extrapolation would be unpredictable.
In regards to HERV and non-human primates, Grandi (HERV-W group evolutionary history in non-human primates: characterization of ERV-W orthologs in Catarrhini and related ERV groups in Platyrrhini, BMC Evolutionary Biology, January 2018, 18, 1-14) teaches that non-human primates have HERV elements (Page 9, column 2, paragraph 3 to Page 10, column 1, paragraph 1). However, Grandi also indicates that HERV loci can be species specific, with orthologs lacking in other species (Page 10, column 1, paragraph 4 to column 2, paragraph 1). This art indicates that HERV loci may be specific to the primate species being examined, and therefore inter-species extrapolation would be unpredictable.
The art supports use of specific subjects. However, methods comprising any subject are highly unpredictable.
The invention is drawn to biological molecules, and is therefore in a class of invention which the CAFC has characterized as “the unpredictable arts such as chemistry and biology.” Mycogen Plant Sci., Inc. v. Monsanto Co., 243 F.3d 1316, 1330 (Fed. Cir. 2001). The level of skill in the art is therefore deemed to be high.
(F), (G) With respect to the amount of direction and working examples provided by the applicant: While the Applicant has provided description of a subject including any multicellular animal, preferably a mammal (paragraph [00149]), the working examples provided by the Applicant are directed to only human subjects. As noted in paragraphs [00187], [00193], and [00194], for example, the samples used in the working examples are clinical samples from humans. This is also apparent throughout the rest of the provided working examples starting from page 37 of the clean copy of the specification filed April 6th, 2023. The Applicant has not provided working examples directed towards any other type of subject.
(H) Undue experimentation would be required to practice the invention as claimed due to the amount of experimentation necessary because of the expansive breadth of the claims, the state of the prior art and its high predictability, and the limited amount of guidance in the form of varied working examples in the specification. A skilled artisan recognizes that a subject very broadly refers to any number of different species and thus applicability of the claimed kit to a subject as embraced by the claims remains unpredictable, requiring undue experimentation. For example, an artisan would need to test the kit on an expansive number of different organisms to determine if it is applicable to detection of a homolog of HERV in said organisms. This reasonably represents undue experimentation.
MPEP §2164.01(a), 4th paragraph, provides that, “A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1157, 1562; 27 USPQ2d 1510, 1513 (Fed. Cir. 1993).
Genentech Inc. v. Novo Nordisk A/S, 42 USPQ2d 1001, 1005 (CA FC), states that, “[p]atent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable,” citing Brenner v. Manson, 383 U.S. 519, 536 (1966) (stating, in the context of the utility requirement, that “a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion”). The Genentech decision continued, “tossing out the mere germ of an idea does not constitute enabling disclosure. While every aspect of a generic claim certainly need not have been carried out by an inventor, or exemplified in the specification, reasonable detail must be provided in order to enable members of the public to understand and carry out the invention.” Id. at p. 1005.
After applying the Wands factors and analysis to claims 1-4 and 6-10, in view of the applicant’s entire disclosure, and considering the In re Wright, In re Fisher and Genentech decisions discussed above, it is concluded that the practice of the full scope of the invention as claimed would not be enabled by the written disclosure. Therefore, claims 1-4 and 6-10 are rejected under 35 U.S.C. §112(a) for failing to disclose sufficient information to enable a person of skill in the art to practice the claimed invention to it the full scope embraced by the claims.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 1 is rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Markovitz (US 20080261216 A1).
Regarding instant claim 1, Markovitz teaches an assay kit for detecting HERV-associated cancer biomarkers for use in detecting cancer in a subject, comprising: (a) a reagent capable of specifically binding to HERV targets, wherein the HERV targets are HERV polynucleotides (Page 15, paragraph [0165]; Claims 19 and 20); (b) a means for detecting the specific binding of the reagent to the HERV targets (Page 15, paragraph [0165]; Claims 19 and 20).
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.
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.
Claims 1-4, 6-8, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Markovitz (US 20080261216 A1).
Regarding instant claim 1, Markovitz teaches an assay kit for detecting HERV-associated cancer biomarkers for use in detecting cancer in a subject (Page 3, paragraph [0020]). Markovitz further teaches that components of the kit include, but are not limited to, hybridization oligonucleotides or polynucleotides, enzymes, buffers, etc. (Page 3, paragraph [0020]).
This particular embodiment does not directly teach that the kit contains (a) a reagent capable of specifically binding to HERV antigens; (b) a means for detecting the specific binding of the reagent to the HERV antigens. However, given that Markovitz teaches that a kit for detecting cancer is not limited to that which is taught in the above cited embodiment, and also given that Markovitz teaches (a) a reagent capable of specifically binding to HERV antigens (Page 14, paragraph [0152]); (b) a means for detecting the specific binding of the reagent to the HERV antigens (Page 14, paragraphs [0152]-[0153]), it would be obvious to include these aspects in a kit for detecting HERV-associated cancer biomarkers.
The above analysis is similarly applicable to teachings of Markovitz directed towards (a) a reagent capable of specifically binding to HERV targets, wherein the HERV targets are HERV polynucleotides; (b) a means for detecting the specific binding of the reagent to the HERV targets. Given that Markovitz teaches that a kit for detecting cancer is not limited to that which is taught in the above cited embodiment, and also given that Markovitz teaches (a) a reagent capable of specifically binding to HERV targets, wherein the HERV targets are HERV polynucleotides (Page 3, paragraph [0020]; Page 11, paragraph [0123]); (b) a means for detecting the specific binding of the reagent to the HERV targets (Page 11, paragraph [0123]), it would be obvious to include these aspects in a kit for detecting HERV-associated cancer biomarkers.
The preamble of this claim recites a “kit.” The specification, however, does not define this term, and so it is being interpreted to encompass any collection of reagents that includes all of the elements of the claims. Any further interpretation of the word is considered an “intended use” and does not impart any further structural limitation of on the claimed subject matter. It is also noted that the claim recites “for use in detecting cancer in a subject.” This is also considered an “intended use” of the kit and does not impart any further structural limitation of on the claimed subject matter.
Regarding instant claim 2, Markovitz teaches the assay kit of claim 1. Markovitz further teaches wherein the reagent capable of specifically binding to a HERV antigen is an anti-HERV antibody (Page 14, paragraph [0151]).
Regarding instant claim 3, Markovitz teaches the assay kit of claim 1. Markovitz further teaches wherein the reagent capable of specifically binding to a HERV antigens is an anti-HERV antibody conjugated to a detection agent (Page 14, paragraph [0153]).
Regarding instant claim 4, Markovitz teaches the assay kit of claim 1, which includes teaching a reagent capable of specifically binding to HERV antigens or HERV targets. Given that claim 4 serves to further limit an optional binding location (HERV-associated antibodies), this claim does not serve to further limit what has been taught by the prior art of claim 1. Therefore, the rejection of claim 1 also serves to reject claim 4.
Regarding instant claim 6, Markovitz teaches the assay kit of claim 1. It is noted by the Examiner that the HERV target is not a part of the kit, and therefore claim 6 does not serve to further limit what has been taught by the prior art of claim 1. However, Markovitz further teaches wherein the HERV target is detected by RT-PCR (Page 11, paragraph [0123]).
Regarding instant claim 7, Markovitz teaches the assay kit of claim 1, which includes teaching a reagent capable of specifically binding to HERV antigens or HERV targets, wherein the HERV targets are HERV polynucleotides. Given that claim 7 serves to further limit an optional HERV target (a marker of HERV expression), this claim does not serve to further limit what has been taught by the prior art of claim 1. Therefore, the rejection of claim 1 also serves to reject claim 7.
Regarding instant claim 8, Markovitz teaches the assay kit of claim 1. Turning to the specification for an interpretation of the claim, it appears that aspects of the kit including primers, buffers, probes, and antibodies are used for immunolabeling and signal detection to increase signal amplification and sensitivity (see paragraphs [0015], [00251], and [00307]). Thus, the claim has been given the broadest reasonable interpretation consistent with the teachings of the specification regarding signal detection to increase signal amplification and sensitivity (In re Hyatt, 211 F.3d1367, 1372, 54 USPQ2d 1664, 1667 (Fed. Cir. 2000) (see MPEP 2111). Given this interpretation, Markovitz further teaches wherein the means for detecting the specific binding of the reagent increases the signal amplification and sensitivity (Page 3, paragraph [0020]; Page 11, paragraph [0123]; Page 14, paragraphs [0151]-[0153]).
Regarding instant claim 10, Markovitz teaches the assay kit of claim 1. Markovitz further teaches the kit further comprising instructions that provide recommendations to assist a treating physician in the course of action, based on the results of the analysis, to optimize patient care (Page 3, paragraph [0020]). In addition, the courts have found that “the content of the printed matter will not distinguish the claimed product from the prior art (In re Ngai, 367 F.3d 1336, 1339, 70 USPQ2d 1862, 1864 (Fed. Cir. 2004)).” See MPEP 2112.01 III. Therefore, because the courts have stated that the inclusion of instructions with an old product is obvious, the instantly claimed instructions are obvious in view of Markowitz.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Markovitz (US 20080261216 A1), as applied to claims 1-4, 6-8, and 10 above, in view of Tsiagbe (US20170334952A1; cited on the IDS filed May 21st, 2025).
Regarding instant claim 9, Markovitz teaches the assay kit of claim 1. Markovitz further teaches wherein the reagent capable of specifically binding to HERV antigens comprises secondary antibodies that are labeled (e.g. conjugated to a label) (Page 14, paragraph [0153]).
Markovitz does not teach that the conjugated label is enzymes or fluorescent dyes.
Tsiagbe, in the same field of endeavor, teaches that a secondary antibody for detection of HERV antigens can be coupled (e.g. conjugated) to a detectable substance, which can be enzymes or fluorescent moieties (e.g. dyes) (Pages 8-9, paragraph [0086]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the unspecified label of Markovitz with the enzymes or fluorescent moieties of Tsiagbe. Since both Markovitz and Tsiagbe are in the same field of endeavor (e.g. detecting HERV biomarkers and kits for detecting HERV biomarkers), one of ordinary skill in the art would combine the two teachings with a reasonable expectation of success. One of ordinary skill in the art would have been motivated to make this modification because it amounts to simple substitution of one known element for another to obtain predictable results (see MPEP 2141(III)). Markovitz already teaches that a secondary antibody may be labeled, so it would be obvious to use label options like enzymes or fluorescent moieties that Tsiagbe teaches can be coupled to secondary antibodies.
Conclusion
All claims are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Allison E Schloop whose telephone number is (703)756-4597. The examiner can normally be reached Monday-Friday 8:30-5 ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne Gussow can be reached at (571) 272-6047. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALLISON E SCHLOOP/Examiner, Art Unit 1683
/Robert T. Crow/Primary Examiner, Art Unit 1683