The examiner of this application in the PTO has changed. To aid in correlating any papers for this application, all further correspondence regarding this application should be directed to Peter Johansen, Group Art Unit 1644, Technology Center 1600.
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on September 18, 2026, has been entered. By way of this submission, Applicant has introduced new claim 69.
Claims 51-64 and 66-69 are pending in the application and under examination before the Office.
The rejections of record can be found in the previous Office action, dated March 20, 2026.
Claim Objections
Applicant is advised that should claim 52 be found allowable, claim 58 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Response to Arguments
Claims 51-64 and 67 were previously rejected under 35 U.S.C. 103 as being unpatentable over anti-Rab5 antibody clone ERP17321 (Abcam.com. Early endosome marker 2015) in view of Li et al (BMC Cancer 16:910, 2016) and Zhao et al (BioMed Research International 2015, Article ID 107149).
Claims 51-64, 66, and 67 were previously rejected under 35 U.S.C. 103 as being unpatentable over anti-Rab5 antibody clone ERP17321 (Abcam.com. Early endosome marker 2015), Li et al (BMC Cancer 16:910, 2016) and Zhao et al (BioMed Research International 2015, Article ID 107149), as set forth above, and further in view of Frittoli et al (JBC 206:307-328, Nov 2014).
Claims 51 and 68 were previously rejected under 35 U.S.C. 103 as being unpatentable over Li et al (BMC Cancer 16:910, 2016) in view of GenBank Homo sapiens RAB5A cDNA Clone MGC 17504 (July 2006) evidenced by Origene's Oligonucleotide Primers.
Applicant argues that Li reports that no significant association between HER1 and HER2 expression and survival was observed, therefore a skilled person reading Li would therefore be discouraged from selecting a HER2 detection reagent as the second component of the kit of claim 51. Applicant further argues that there is no motivation to combine the cited references in order to arrive at the claimed invention, especially as Zhao provides no reason to pair a RAB5 reagent with a HER2 reagent. Applicant further argues that a combination of levels of HER2 and RAB5 performs better than either biomarker alone for cellular T-DM1 response.
Applicant's arguments are persuasive, and the above rejections are hereby withdrawn.
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.
Claim 69 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. This is a new grounds of rejection.
Claim 69 refers to "[t]he method of claim 63". There is insufficient antecedent basis for this term, as claim 63 recites only a kit, and not a method.
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.
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.
Claims 51, 53-57, 59-63, and 68-69 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Reese (US20160069883A1). This is a new grounds of rejection.
Reese teaches that RAB5A and ERBB2 (i.e. HER2) are relevant biomarkers for determining whether a subject has or is at risk of having breast cancer (para. 0011).
Reese teaches a kit that can detect at least two or three biomarkers for breast cancer, such as RAB5A and ERBB2 (para. 0110), which is pertinent to claim 51 and 53-54.
Reese further teaches that such biomarkers are useful for detecting breast tumors (para. 0093).
Reese further teaches that such biomarkers may be detected by nucleic acid probes (para. 0015 and 017-0108), which is pertinent to claim 55.
Reese further teaches that such biomarkers may be detected by immunoassay or immunohistochemistry with antibodies (para. 0100-0101), which is pertinent to claims 56, 57, 59. and 60.
Reese further teaches that the kit may include suitable detection reagents (para. 0111), which is pertinent to claim 61.
Reese further teaches that CEA is also a biomarker for breast cancer (para. 0011), which is pertinent to claims 63 and 69.
Reese further teaches that the kit may include primers for specific amplification of a biomarker gene of interest (i.e., an "amplification nucleotide") (para. 0110), which is pertinent to claim 68.
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 52, 58, and 66 are rejected under 35 U.S.C. 103 as being unpatentable over Reese as applied to claim 51 above, and further in view of Frittoli (J Cell Biol. 2014 Jul 21;206(2):307-28, cited previously). This is a new grounds of rejection.
The teachings of Reese have been discussed supra. However, Reese does not teach that RAB5A is expressed on cancer cells, or RAB4.
Frittoli teaches that RAB5A expression is significantly elevated in lymph node metastases with respect to matched human primary breast tumors (page 309, left column, third paragraph).
Frittoli further teaches that RAB4 is also amplified in invasive breast cancer, as shown by immunohistochemistry (Figure 10).
It would have been prima facie obvious for a person of ordinary skill in the art as of the effective filing date to combine the teachings of Reese and Frittoli to arrive at the claimed invention. An ordinary artisan would have been motivated to do so, and have a reasonable expectation of success, since both Reese and Frittoli are concerned with analyzing biomarkers for breast cancer. As Reese teaches, kits for the detection of RAB5A and ERBB2 (i.e. HER2) for the purpose of breast cancer diagnosis were known in the art. Frittoli teaches a connection between RAB5A and RAB4 are they relate to breast cancer, including examining RAB4 expression by immunohistochemistry. One of ordinary skill could apply the RAB4 of Frittoli to the kit of Reese by known methods, with each component of the combination performing its known, usual function, and the combination would yield nothing more than predictable results.
Claim 64 is rejected under 35 U.S.C. 103 as being unpatentable over Reese as applied to claim 51 above, and further in view of Witton (J Pathol. 2003 Jul;200(3):290-7). This is a new grounds of rejection.
The teachings of Reese have been discussed supra. However, Reese does not teach HER1.
Witton teaches that overexpression of HER1 and HER2 is associated with reduced survival of patients with breast cancer (abstract and Figure 1).
Witton also teaches that it is useful to evaluate HER1 and HER2 expression levels in breast cancer in order to determine a proper treatment (page 295, right column)
It would have been prima facie obvious for a person of ordinary skill in the art as of the effective filing date to combine the teachings of Reese and Witton to arrive at the claimed invention. An ordinary artisan would have been motivated to do so, and have a reasonable expectation of success, since both Reese and Witton are concerned with analyzing biomarkers for breast cancer. As Reese teaches, kits for the detection of RAB5A and ERBB2 (i.e. HER2) for the purpose of breast cancer diagnosis were known in the art. Witton further teaches that both HER1 and HER2 are clinically relevant biomarkers for breast cancer, and are useful for informing treatment. One of ordinary skill could apply the HER1 of Witton to the kit of Reese by known methods, with each component of the combination performing its known, usual function, and the combination would yield nothing more than predictable results.
Claim 67 is rejected under 35 U.S.C. 103 as being unpatentable over Reese as applied to claim 51 above, and further in view of Chinnaiyan (US20080207714A1). This is a new grounds of rejection.
The teachings of Reese have been discussed supra. However, Reese does not teach a computer-based analysis program for translating raw data generated by the use of the reagent for detection into data of predictive value for a clinician.
Chinnaiyan teaches methods of assessing the risk of breast cancer in a subject, comprising detecting a biomarker in a sample from the patient (para. 0012).
Chinnaiyan further teaches kits containing methods for detecting said biomarkers (para. 0119-0121).
Chinnaiyan further teaches a computer-based analysis program to translate the raw data generated by the detection assay (e.g., the presence, absence, or amount of a biomarker) into data of predictive value for a clinician (para. 0103).
It would have been prima facie obvious for a person of ordinary skill in the art as of the effective filing date to combine the teachings of Reese and Chinnaiyan to arrive at the claimed invention. An ordinary artisan would have been motivated to do so, and have a reasonable expectation of success, since both Reese and Chinnaiyan are concerned with analyzing biomarkers for breast cancer. As Reese teaches, kits for the detection of RAB5A and ERBB2 (i.e. HER2) for the purpose of breast cancer diagnosis were known in the art. Chinnaiyan teaches that computer-based analysis programs are useful to translate data from biomarker assays into data of predictive value for a clinician. One of ordinary skill could apply the program of Chinnaiyan to the kit of Reese by known methods, with each component of the combination performing its known, usual function, and the combination would yield nothing more than predictable results.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Yang (Cancer Sci. 2011 Dec;102(12):2172-8, cited in IDS) teaches immunohistochemical staining of RAB5A in breast cancer samples (Figure 6).
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PETER JOHANSEN whose telephone number is (571)272-0280. The examiner can normally be reached Monday-Friday, 6:00 to 2:00.
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/PETER JOHANSEN/Primary Examiner, Art Unit 1644
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