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 .
This application has been transferred to a different Examiner.
Election/Restrictions
Applicant’s election without traverse of Group II, claims 7-9 in the reply filed on 8/25/2024, is acknowledged. Claims 29-34 we added. Claims 1,6,10-15,17,22,24 and 26-27 were cancelled.
Applicant’s election of species, of claim 30, amended to depend from claim 29, in the reply filed on 11/11/2025, is acknowledged.
Claim 9 and 31 were withdrawn by applicant, these being drawn to a non-elected species. However, in view of claim 7 being free of the art as discussed below, the Examiner’s search has been extended to what were the withdrawn species, claims 9 and 31, which are no longer withdrawn.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. ARP 20190103911 12/30/2019.
Drawing Objections
The drawings are objected to for the following reasons:
FIGs. 1-8, and 10 view are in landscape format, must be rotated, such that the top becomes the left-hand side. Additionally, Figure labels recite "Figure" instead of "FIG."
37 CFR 1.84(i) states “All views on the same sheet should stand in the same direction and, if possible, stand so that they can be read with the sheet held in an upright position. If views wider than the width of the sheet are necessary for the clearest illustration of the invention, the sheet may be turned on its side so that the top of the sheet, with the appropriate top margin to be used as the heading space, is on the right-hand side.”
In the current case, the view of Figures 2-8, and 10 are such that it is necessary to rotate the sheet. However, the orientation of the Figure on the sheet incorrectly necessitates the rotation of the sheet such that the top of the sheet becomes the left-hand side. A replacement sheet should be provided that reverses the orientation of the Figure such that the top of the sheet becomes the right-hand side after rotation.
37 CFR 1.84 (u)(1) states “View numbers must be preceded by the abbreviation "FIG."”
In the current case, the view numbers for all of the Figures are preceded by the word "Figure" instead of the abbreviation "FIG.".
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 disclosure is objected to because of the following informalities:
Throughout the Specification, reference is made to “a” and “13” subunits, instead of to “α” and “β” subunits. One example of this is found on Page 1, lines 33 and 35. All recitations need to be corrected.
Similarly, what is presumed to be SDS PAGE is referenced as SOS PAGE. Examples are found on Page 3, lines 33 and 36, and there are more of these recitations throughout the Specification which need to be corrected.
On Page 30, in appropriate symbols are found in the “P%” column of the Table on this page, in the Total row, as depicted below:
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On Page 31 is what appears to be an empty Table:
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Also on Page 31, the Table following the one above appears to have empty “Chi Square Statistic” and “Critical Value” boxes, and the numeric values appear to be to the right of the empty boxes for these values. Similarly, in addition to 0.6 for the presumed P-value, the number 507 appears in the P-value row.
Appropriate corrections are required.
The use of the term Novormon, which is a trade name or a mark used in commerce, has been noted in this application (e.g. at least on Pag 4, line 9). 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
Claims 8,9 and 33 are objected to because of the following informalities:
Claims 8 and 9 are objected to because of the use of “it”, in combination with wherein, which is grammatically incorrect and can be more clearly stated. Avoidance of the pronoun “it” provides clarity, (and wherein already refers back to the cell line).
If this is the intent, two acceptable choices are for claim 8: the cell line of claim 7, wherein the cell line is a CHO-K1 cell line, or to avoid redundancy, The cell line of claim 7 is a CHO-K1 cell line. Or use of said cell line, consistent with other claims, would work.
Similarly, for claim 9, if this is the intent, one option would be: the cell line of claim 7, wherein the cell line produces recG having an activity of at least 100 IU/ml reCG.
Claim 33 is objected to because it is missing an indefinite article, in the recitation of the EF-1a promoter. Proper correction would be: “…that contains an EF-1a promoter.”
Appropriate correction is required.
Claim interpretation
In evaluating the patentability of the claims presented in this application, the claims will be given their broadest reasonable interpretation, in view of the specification, and as set forth at MPEP§ 2111. For clarity of the record,
Claim 30 recites: between 26 and 30%, between 50 and 55% and between
8 and 15%. The use of “between” can be ambiguous regarding end points. Here, between will be interpreted to include all end points such that e.g., “between 26 and 30%” includes 26 % and 30% as well as all values in between.
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 31-34 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 31 is indefinite over the recitation of the parenthetical, “(in vivo potency units relative to mass determined by ELISA)” because the use of parentheses makes it unclear whether what is enclosed by them is a requirement of the claim.
Claim 32 is indefinite over the recitation of “most suitable”. Claims 33 and 34 depend from claim 32 and are indefinite for the same reason. “Most suitable” is a relative term, and a subjective term, therefore, it is not possible to establish the metes and bounds of the claim as written.
Claim 33 recites the limitation, ”…comprise the pLV lentiviral vector …”. There is insufficient antecedent basis for this limitation in the claim. Claim 34 depends from claim 33 and are indefinite for the same reason.
Prior Art
The identical sequences to instant SEQID Nos: 1 and 2, have not been identified in the prior art in a manner that would anticipate or render obvious the instant claims.
The closest sequence to SEQ ID NO: 1 is found in Chen (US2018/0139938 A1; published May 24, 2018), which is not a perfect match to instant SEQ ID NO: 1. Chen disclosed a method to provide a transgenic mammal to express a fusion protein, and to then harvest milk from said mammal (claim 1). Chen’s SEQID NO:4 is a sequence for an eCG α subunit-Fc fusion ([0014]). Chen’s SEQID NO:4 is a “90% match” to the instant application SEQ ID NO: 1, the alignment displayed below, where it is also shown that the length of the Chen SEQID NO:4 is 1089 bp, much longer than the 366 base pairs of the instant SEQID NO: 1, thus Chen SEQID NO:4 and instant SEQID NO:1 are not similar for art purposes.
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Baruffi et al. (US20220267401,filed 5/10/2016) disclosed a method for producing recombinant equine chorionic gonadotropin (reCG), comprised of α and β subunit, where the α subunit is mammalian, the β subunit is equine, and these are fused. Vectors for expression of the hormone include CHO-K1and HEK 293 (Abstract).
Additional art, Sogayar et al (WO2020172728 A1, efd 12/26/2019) disclosed a method for producing recombinant equine chorionic gonadotropin, obtaining DNA sequence encoding reCG α and β chains, inserting the DNA into expression vectors, engineering a cell line with the genomic insert, cotransfecting the reCG α and β chain vectors into the cell line, isolating particular phenotypes, identifying clones/phenotypes associated with production of active reCG, culturing the clones and recovering active reCG from the culture. The process involves α and β chain coding sequences but not the sequences in the instant application.
The closest art for instant SEQID NO: 2 was identified as Chen (WO 2016178087 A1, published 2016-11-10), a method for producing subunits of equine chorionic gonadotropin protein, providing a transgenic mammal modified to expression subunits of CG protein, where the two subunits are Chen’s SEQ ID NO: 1 and SEQ ID NO: 2 (claims 1 -4). The specification discloses that in some embodiments the nucleic acid sequence encoding eCG β subunit comprises SEQID NO:7 or may be at least 60% similar. While Chen SEQID NO: 7 is 507 bp and an 81% match to instant SEQ ID NO: 2 (shown below) which is 513 bp, the selection of the exact species of instant SEQ ID NO: 2, from the exceptionally large Genus of sequences 60% similar to Chen’s SEQ ID NO: 7 is not obvious, given the very large number of permutations of SEQID NO: 7 possible in Chen (e.g. if 60% of sites were modified, or 304 of the 513 sites, with four nucleotide choices per site, this would be 1.06e+183 permutations). To select instant SEQID NO:2 from this, would not be obvious.
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Conclusion
Claim 7, 29 and 30 are allowed. Claims 8, 9 and 33 are objected to for minor informalities and claims 31-34 are rejected. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Lisa Horth whose telephone number is (703)756-4557. The examiner can normally be reached Monday-Friday 8-4 EST.
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/LISA HORTH/Examiner, Art Unit 1681
/NEIL P HAMMELL/Supervisory Patent Examiner, Art Unit 1636