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 of Group I, claims 1, 2, 4, 8-9, 13-15, 18, 22-23, 29-31, 33, 35, 43 and 45 in the reply filed on 12/19/25 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Currently, claims 1-2, 4, 8-9, 13-15, 18, 22-23, 29-31, 33, 35, 43, 45, 47 and 50 are pending. Claims 47 and 50 are withdrawn as being directed to non-elected inventions. Accordingly, claims 1-2, 4, 8-9, 13-15, 18, 22-23, 29-31, 33, 35, 43 and 45 are under examination.
NOTE: Claims 16-17 were indicated as being canceled by the Applicant in the remarks filed 06/29/23. However, claims 16-17 in the listing of claims submitted 06/29/23 have a status identifier of (Original claims) and then are recited limitations which have been lined through. This is considered inappropriate and could cause confusion as to if the claims were actually canceled or not. In view of the Applicant statement in the remarks filed 06/29/23 that the claims are canceled and in light of the fact that the Applicant did not argue the claims being removed from the restriction requirement filed 08/27/25 the claims appear to indeed be canceled. In order to expedite prosecution the Examiner has interpreted claims 6-17 as being canceled.
Information Disclosure Statement
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.
Drawings
The drawings are objected to because Figures 14A and 14B 2 discloses nucleotide sequences and amino acid sequences without disclosing the appropriate sequence identifier in the drawing. 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.
Abstract
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The instant abstract utilized implied phrases see “The disclosure relates to”. This language should be avoided.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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 23 and 35 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 23 a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) is considered indefinite, since the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). Note the explanation given by the Board of Patent Appeals and Interferences in Ex parte Wu, 10 USPQ2d 2031, 2033 (Bd. Pat. App. & Inter. 1989), as to where broad language is followed by "such as" and then narrow language. The Board stated that this can render a claim indefinite by raising a question or doubt as to whether the feature introduced by such language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Note also, for example, the decisions of Ex parte Steigewald, 131 USPQ 74 (Bd. App. 1961); Ex parte Hall, 83 USPQ 38 (Bd. App. 1948); and Ex parte Hasche, 86 USPQ 481 (Bd. App. 1949). In the present instance, claim 23 recites the broad recitation ratio 2:20 to 1:2000 and the claim also recites 1:20 to 1:500 which is the narrower statement of the range/limitation. The claim recites multiple scenarios of different ratio ranges which fall with a broad range or limitation together with a narrow range.
Claim 35, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim Rejections - 35 USC § 102
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 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, 2, 4 and 29-31 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hoglund et al (International Journal of Molecular Sciences, September 29, 2019, 20, pages 1-19)(submitted in the IDS filed 01/17/23).
Hoglund et al discloses a method of cleaving an antibody comprising digestion of antibodies with cathepsin L (e.g. Fig’s 3 &7, page 13). Hoglund et al discloses that the antibodies are IgG antibodies (e.g. title, pages 2, 5, 9). Hoglund et al discloses that the digestion can occur at a pH of 4 or 5 and at a temperature of 37 degrees celcius (e.g. p. 13). Hoglund et al discloses that the cathepsin to antibody ratio can be 1-100 to 1:300) (e.g. page 13). Hoglund et al discloses performing mass spectrometry on the digested sample (e.g. pages 13-14). Hoglund et al discloses the antibodies are cut at light and heavy chains or the variable region (e.g. pgs 5-7). Hoglund et al discloses that the mass spectrometry can be performed by electrospray ionization (e.g. page 14). Hoglund et al discloses detecting amino acid fragments of 6-40 amino acids (e.g. page 12). Hoglund et al discloses determining a CDR region of the antibody (e.g. pages 10-11 and 13).
With respect to the recitation “wherein the antibody comprises a light chain comprising a light chain variable region (VL) and a light chain constant region (CL) and a heavy chain comprising a heavy chain variable region (VH) and a heavy chain constant region (CH), and wherein the cathepsin L and/or D cleaves the antibody between the VL and CL and/or between the VH and CH regions to create VL and/or VH antibody fragments and CL and/or CH antibody fragments” as recited in the instant claims. Hoglund et al discloses the same cathepsin and the same antibody as currently recited and therefore the antibody would comprise the same heavy and light chains as currently recited and would be cleaved between the regions recites.
Further, the Patent and Trademark Office does not have the facilities and resources to provide the factual evidence needed in order to establish that there is a difference, in the first place between the cathepsin and the antibody of Hoglund et al and those instantly recited and, that if there is such a difference, that such a difference would have been considered unexpected, i.e. unobvious by one of ordinary skill in the art. The burden is upon applicant to present such factual evidence. See e.g. In re Best (195 USPQ 430(CCPA 1977).
Claims 1, 2, 4, 43 and 45 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bee et al (Biotechnol. Prog., 2015, Vol. 31, No. 5, 1360-1369) (submitted in the IDS filed 01/17/23).
Bee et al discloses a method of cleaving an IgG antibody by mixing cathepsin D with the antibody to obtain fragments of the antibody (e.g. abstract, figure 6, Tables 2-3). Bee et al discloses that the cleaved fragments are subjected to mass spectrometry (e.g. tables 2-3). Bee et al discloses that the antibodies have not been reduced (e.g. table 3).
With respect to the recitation “wherein the antibody comprises a light chain comprising a light chain variable region (VL) and a light chain constant region (CL) and a heavy chain comprising a heavy chain variable region (VH) and a heavy chain constant region (CH), and wherein the cathepsin L and/or D cleaves the antibody between the VL and CL and/or between the VH and CH regions to create VL and/or VH antibody fragments and CL and/or CH antibody fragments” as recited in the instant claims. Bee et al discloses the same cathepsin and the same antibody as currently recited and therefore the antibody would comprise the same heavy and light chains as currently recited and would be cleaved between the regions recites.
Further, the Patent and Trademark Office does not have the facilities and resources to provide the factual evidence needed in order to establish that there is a difference, in the first place between the cathepsin and the antibody of Bee et al and those instantly recited and, that if there is such a difference, that such a difference would have been considered unexpected, i.e. unobvious by one of ordinary skill in the art. The burden is upon applicant to present such factual evidence. See e.g. In re Best (195 USPQ 430(CCPA 1977).
Claims 1 and 43 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bee et al (Biotechnol. Prog., 2015, Vol. 31, No. 5, 1360-1369).
Verity et al discloses combining cathepsin D and IgG (e.g. abstract, page 416) and that the cathepsin D cleaves the IgG (e.g. pg 419). Verity et al discloses that the mixture is not treated with a denaturing or reducing agent (e.g. pgs 416-418, Table 1).
With respect to the recitation “wherein the antibody comprises a light chain comprising a light chain variable region (VL) and a light chain constant region (CL) and a heavy chain comprising a heavy chain variable region (VH) and a heavy chain constant region (CH), and wherein the cathepsin L and/or D cleaves the antibody between the VL and CL and/or between the VH and CH regions to create VL and/or VH antibody fragments and CL and/or CH antibody fragments” as recited in the instant claims. Verity et al discloses the same cathepsin and the same antibody as currently recited and therefore the antibody would comprise the same heavy and light chains as currently recited and would be cleaved between the regions recites.
Further, the Patent and Trademark Office does not have the facilities and resources to provide the factual evidence needed in order to establish that there is a difference, in the first place between the cathepsin and the antibody of Verity et al and those instantly recited and, that if there is such a difference, that such a difference would have been considered unexpected, i.e. unobvious by one of ordinary skill in the art. The burden is upon applicant to present such factual evidence. See e.g. In re Best (195 USPQ 430(CCPA 1977).
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.
Claims 8-9, 13-15, 18, 22-23, 33 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Hoglund et al in view of Tang et al., (67th ASMS Conference on Mass Spectrometry and Allied Topics 2 June 2019, pages 1-295) (submitted in the IDS filed 01/17/23).
See above for the teachings of Hoglund et al.
Hoglund et al differs from the instant invention in failing to teach the antibody is cleaved with a combination of cathepsin L and cathepsin D.
Tang et al shows that it is known and conventional in the art to use cathepsin L and D for the cleavage of antibodies to be analyzed by mass spectrometry (e.g. WP 058, page 146).
It would have been obvious before the effective filing date of the claimed invention to a person having one of ordinary skill in the art to incorporate both cathepsin L and D for the cleavage of the antibody in the method of Hoglund et al because Tang et al shows that it is known and conventional in the art that both can be used for the cleavage of antibodies. Thus, one of ordinary skill in the art would have a reasonable expectation of success incorporating both cathepsin L and D for the cleavage of the antibody in the method of Hoglund et al.
With respect to claim 13 as currently recited. Hoglund et al discloses the same cathepsin and the same antibody as currently recited and therefore the cleavage would result in VL, VH, CL, CH1, CH2, CH2-CH2, CL+CH1 (bonded), F(ab’) and F(ab’)2 fragments.
With respect to the percentage of solvent as recited in claims 14, 18 and 22. The optimum percentage of organic solvent can be determined by routine experimentation and thus would have been obvious to one of ordinary skill in the art. Further, it has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value of a result effective variable. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation.” Application of Aller, 220 F.2d 454,456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). “No invention is involved in discovering optimum ranges of a process by routine experimentation .” Id. At 458,105 USPQ at 236-237. The “discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” Application of Boesch, 617 F.2d 272,276, 205 USPQ 215, 218-219 (C.C.P.A. 1980).
With respect to claim 9 as currently recited. It would have been obvious before the effective filing date of the claimed invention to a person having one of ordinary skill in the art to incubate the antibody and cathepsin L and D simultaneously because the combination of Hoglund et al and Tang et al teach combining the antibody with L and D and thus to add individually or simultaneously would be an obvious design choice and further because it has been held that merely reversing the order of steps in a multistep process is not a patentable modification absent unexpected or unobvious results, Ex parte Rubin, 128 U.S.P.Q.440 (P.OB.A. 1959). Cohn v. Comr. Patents, 251 F. Supp. 437, 148 U.S.P.Q. 486 (D.C. 1966).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GARY W COUNTS whose telephone number is (571)272-0817. The examiner can normally be reached M-F 7:00-4:00.
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/GARY COUNTS/ Primary Examiner, Art Unit 1678