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
Amended claims 1, 13-19, 21, 23, 31 are pending.
Claim 31 stands withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 04/23/2026.
Claims 1, 13-19, 21, 23, and species of 1q31 as the locus and LAMB3 as the gene of interest are examined here.
Priority
The claims benefit of 63/155,504, filed on 03/02/2021, via its PCT/US2022/01 8246, filed on 03/01/2022, is recognized. All examined claims enjoy the benefit date of ‘504 filing.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/31/2026 and its fee was filed before the mailing date of this Action. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The objection of drawing based on Fig. 7 is withdrawn; a replacement sheet of Fig. 7 is submitted.
Specification
The objection regarding embedded https: is withdrawn, the specification of 07/31/26 deletes “https.”
Improper Markush
Rejection of cl. 2-4 under Improper Markush is withdrawn, the claims are canceled.
Claim Rejections - 35 USC § 112
35 U.S.C. 112(a)
The rejection of cl. 1, 13-19, 21 and 23 is maintained under 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.
Claims 1, 13-19, 21 and 23 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites a “safe harbor site” (SHS, also called genomic safe harbor (GSH)) in claimed coordinates 195,338,589-195,818,588 of GRCh38/hg38. The recited site is some 480,000 bp. region.
In analyzing whether the written description requirement is met for genus claims, it is first determined whether a representative number of species have been described by their complete structure. In the instant case, the only species whose complete structure is disclosed for the claimed coordinates, are the flanking sequences within SEQ ID NO: 1 and SEQ ID NO: 3 (pg. 61-65) or SEQ ID NO: 25 (“HA left” or left homology arm) and SEQ ID NO: 45 (“HA right” or right homology arm), both of which are 1000 nt. each and can be inserted as homologous arms (pg. 34, line 21-25; pg. 36, line 3-7; pg. 70-71). Both flanking regions of SEQ ID NO: 1/3 are the same sequences for GSH1 engineered nucleic acid and target chromosome 1 (pg. 61-65) and are a subsequence within SEQ ID NO: 25 or 45. While the genus 1q31 encompasses a large number of variants that have the same activity of a safe harbor site (SHS) within 1q31 and have a different sequence, i.e. structure. The specification does not describe the complete structure of a representative number of species of the large genus of SHS within the claimed coordinates.
Further, it appears these “targeting vectors” based on experiments conducted do not appear to integrate in the chromosome successfully. E.g., Fig. 2G and 2H illustrate that the integration is dependent on various factors, include sequence of the homologous arm, cell-type and chromosome. In Jurkat cells only GSH1 (i.e. chromosome 1 targeting vector) and GSH2 (chromosome 3 targeting vector) are different from untransfected cells in terms of fluorescence levels, while for GSH7, GSH8, and GSH31 the fluorescence levels are not different from untransfected cells (see Fig. 2H). Fig. 2G, tested in HEK293T cells, illustrates increased number of targeting vectors that are more successful (GSH1, GSH2, GSH7, and GSH31, pg. 6, lines 28). Thus, it appears some targeting vectors did not integrate at level to distinguish it from background fluorescent levels; thus, not all flanking homologous arms may be able to function as a “targeting vector” in integrating into the SHS/GHS of a human chromosome. Thus, e.g., for GSH1 only a portion of 1000 nt. sequence length (i.e. length of SEQ ID NO: 25 and 45) was tested that was within the large ~480,000 base length of claimed coordinates.
Next, then, it is determined whether a representative number of species have been sufficiently described by other relevant identifying characteristics (i.e. other than nucleotide sequence), specific features and functional attributes that would distinguish different members of the claimed genus. In the instant case, the only other identifying characteristic is the criteria used to identify the SHS sites in the chromosome, see Fig. 1A-B (e.g., 50 kb away from known genes, 300 kb away from known oncogenes, etc. . . ). Such a functional limitation based on these criteria cannot be an identifying characteristic for the claimed diverse genus of molecules since by Applicant’s definition of SHS within the claimed coordinates, all members of the claimed genus will have that characteristic, see Table 1, pg. 13-14, noting quite a few sites within chromosome 1). It is difficult to envision the structure, i.e. the sequences, based on the criteria noted that is also a safe harbor site.
The inventions of dependent claims 13-19, 21, 23 require the use of the inventions of claim 1 and therefore are likewise rejected under 35 U.S.C. 112, first paragraph, as failing to comply with the written description requirement.
Applicant’s attention is directed to the Guidelines for the Examination of Patent Applications Under the 35 U.S.C. 112(a) or Pre-AIA 35 U.S.C. 112, first paragraph, "Written Description" Requirement (MPEP2163).
In conclusion, Applicant’s disclosure of one species of each homologous arm (i.e. SEQ ID NO: 25/45 of elected 1q31) of one site within the claimed broad genus of claimed SHS coordinates is not deemed sufficient to reasonably convey to one skilled in the art that Applicant was in possession of the claimed broad genus at the time the application was filed. Thus, it is concluded that the written description requirement is not satisfied for the claimed genus.
Enablement:
Claim 1 and its dependents (13-19, 21, 23) are rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, as based on a disclosure which is not enabling. The disclosure does not enable one of ordinary skill in the art to practice the invention without the nucleic acid sequence between the recited coordinates, which is/are critical or essential to the practice of the invention but not included in the claim(s). See In re Mayhew, 527 F.2d 1229, 188 USPQ 356 (CCPA 1976).
The attempt to incorporate subject matter into this application by reference to GRCH38/hg38 is ineffective because the recited coordinates refer to essential a Genome Reference Consortium Human Build 38 (“GRCh38”) (official name for the current major release of the human genome reference assembly; hg38 is an unofficial name). Here it is an essential material since the sequence pinpoints to the specific location of the chromosome of insertion. “Essential material” may be incorporated by reference, but only by way of an incorporation by reference to a U.S. patent or U.S. patent application publication, which patent or patent application publication does not itself incorporate such essential material by reference. Here, the claims are, in effect, incorporating the sequence contained in an electronic database. See MPEP 608.01(p). Accordingly, the reference to the online genomic sequence does not provide the features that are critical or essential to the practice of claimed invention.
One way to obviate both of the rejections noted above is by reciting specific SEQ ID NOs.
Response to Arguments
Written Description:
Applicant's arguments filed 07/31/2026 (“the Remarks”) have been fully considered but they are not persuasive.
The Remarks traverse the rejection based on the following arguments (pg. 7-8):
The claimed coordinate range corresponds to a specific, fully-sequenced, publicly known segment of the human reference genome (pg. 7). The claimed coordinates satisfies written description requirement by disclosing SEQ ID NOs: 1, 3, 25 and 45 and structural feature common to every member of the claimed genus is now precisely stated: “each member is subsequence of one specific, publicly known ~480,000 bp reference sequence” (pg. 7).
The argument is not persuasive.
The claimed subject matter is not claiming solely the sequence lying within the claimed coordinates. The claimed subject matter encompasses target vector comprising homologous arms with a functional limitation of recognizing safe harbor site for integration in a human genome. The specification, as noted in the previous/instant action, demonstrates that some target vectors comprising homologous arms are not able to integrate in a human genome (pg. 6 of 06/16/26 action, citing GSH7, GSH8, GSH31). Integration process requires knowing the sequence and structure of the safe harbor site that allows integration. Here, the specification is in possession of some ~2000 base pairs (SEQ ID NOs: 25 and 45) that is capable of meeting the functional limitation of homologous arms that are capable of incorporating in SHS while the claim attempts to claim ~500,000 base pairs.
Thus, rejection of examined claims is maintained.
112(a) Enablement:
Applicant's arguments filed 07/31/2026 (“the Remarks”) have been fully considered but they are not persuasive.
The Remarks traverse the rejection based on the following arguments (pg. 8-9):
The “essential material” is not implicated here, since “an art-standard extrinsic reference system, the location of naturally occurring, publicly available, stable segment of the human genome, precisely as a gene symbol, cytogenetic band, or GenBank/RefSeq accession number would. The sequence residing at that location is not the claimed invention and is not ‘essential material’ being smuggled into the claim by reference. It is fully public, freely retrievable natural sequence” (pg. 8).
Retrieving the sequence is not “undue experimentation” (pg. 8).
The argument is not persuasive.
Prior action specifically indicates the purpose behind this rejection: “the claims are, in effect, incorporating the sequence contained in an electronic database” (pg. 8 of 06/16/26 action), which the instant Remarks recognizes as “art-standard extrinsic reference system.” The issue is that it is unknown for how long a particular version (hg38) and/or the database (“extrinsic reference system”) is maintained or will exist. Similarly, it is unknown how long the body (i.e. the Genome Reference Consortium) maintaining the system will exist. Similarly, claims are not allowed GenBank/RefSeq accession number, since it is a sequence in a distinct database, but rather SEQ ID NOs are required for claims, with SEQ ID NO maintained at least in a U.S.P.T.O. database.
The issue of undue experimentation was not raised so it is not relevant.
The rejection of claim 1 and its dependents (13-19, 21, and 23) is maintained.
35 U.S.C. 112(b)
Rejection of cl. 17 under 112(b) for referencing a table is withdrawn, as the claim deletes references to Table 2.
Rejection of cl. 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 1, 13-19, 21, and 23 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 1 recites “wherein the safe harbor site is on the long arm of the chromosome 1 (1q31.3) within coordinates 195,338,589-195,818,588”. 1q31.3, in parenthesis, comprises the coordinates 193,800,001-198,700,000, which is longer than coordinates specifically recited (the size is based on Genome Data Viewer on NCBI’s website [www.ncbi.nlm.nih.gov/gdv/browser/genome/?id=GCF_000001405.40, accessed 09/29/2026]). It is not clear if the claimed invention comprises the coordinates encompassed by 1q31.3, creating confusion regarding which coordinates the claim means and thus the claimed invention is indefinite regarding the metes and bounds of the scope of the claim.
Claims 13-19, 21, 23 do not overcome the indefiniteness, thus are rejected.
Claim 1 recites coordinates that refers to Genome Reference Consortium Human Build 38 (“GRCh38”) and is the “official name for the current major release of the human reference assembly”; GRCh38 is also referred to as “hg38” in the UCSC Genome Browser but is not an official assembly name or abbreviation (see Frequently Asked Questions, www.ncbi.nlm.nih.gov/grc/help/faq/, accessed 06/01/2026, pg. 1). Thus the reference assembly can change over time and GRCh38 is the “current” human reference genome assembly. Here, the recitation of specific site based on a version of a genomic build is arbitrary without a point of reference. An “address” only provides a location, but not the residents (i.e. the sequence) of the residence. The claims do not refer to any particular genomic sequence for chromosome 1 and the sequences may have different numbering schemes due to polymorphic nature of chromosome 1 or the improvement in technology in “building” the sequence of chromosome 1. Thus the coordinates associated with current GRCh38/hg38 may change and therefore is indefinite.
Dependent claims do not overcome the indefiniteness.
For the purposes of rejections, the broader sequence region (1q31.3) will be used.
Response to Arguments
Applicant's arguments filed 07/31/2026 (“the Remarks”) have been fully considered but they are not persuasive.
The Remarks insist on the following to overcome the indefiniteness rejection:
The amended claim recites specific coordinates and citing the each GRCh38 patch release confirms: “No chromosome coordinates changed” (pg. 9).
The Examiner conflates the possibility that GRCh38 will eventually be superseded by a differently-named assembly with the actual practice under which GRCh38’s own coordinates do not change (pg. 10). Then provides an anecdotal example: one application’s recitation of SEQ ID NO: 1 is not indefinite because some later, unrelated application might define a different SEQ ID NO: 1, because GRCh38’s primary-assembly coordinates are fixed (pg. 10).
The argument is not persuasive.
Frequently Asked Questions (Genome Reference Consortium, pages 1-7, accessed 06/02/2026, cited in a prior action), at pages 2-7 explains that the sequence changes over time. Minor releases are recognized by the suffix “.p” where GRCH38.p9 is the ninth release. Updates can make corrections to the sequence without changing the chromosome coordinates. The underlying sequence can change, see “What are fix patches?” (pg. 2). Also see Magali (2014; cited in a prior action). The reference discusses the reason for patches was to fix sequence differences that were noticed (pg. 2); arguably identification of specific patch may alleviate the 112(b) rejection. Allelic variance would also have the same coordinates. Thus, the rejection is maintained.
Claim Rejections - 35 USC § 101
Rejection of claims 1, 13-16, 18-19 and 23 is maintained.
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 13-16, 18-19, 23 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more.
Claim 1 recite(s) an “engineered nucleic acid targeting vector comprising an exogenous sequence of interest flanked by homology arms, each homology arm comprising a sequence homologous to a sequence in a safe harbor site in a human genome,” wherein the SHS is in the recited coordinates (interpreted under 112(b) as the broader 1q31.3).
Here, the claimed subject matter is a composition of matter but is directed to the judicial exception as a law of nature or a natural phenomenon, i.e. a nature based product. The claimed characteristics are not markedly different from the product’s naturally occurring counterpart in the natural state, i.e. a dsDNA sequence within the 1q31.3 region of the chromosome. The specification indicates that a vector can be a double-stranded DNA vector (pg. 2, line 28), which encompasses a chromosome as well.
Regarding instant cl. 1, 13-16, 18 and 19, human chromosome region 1q31.3 (as interpreted under 112(b) rejection) comprises an open reading frame, e.g., gene CFHR1 (genome.ucsc.edu/cgi-bin/hgTracks?db=hg38&lastVirtModeType=default&lastVirtModeExtraState=&virtModeType=default&virtMode=0&nonVirtPosition=&position=chr1%3A193800001-198700000&hgsid=4183529437_9H2hgUOlIXCBGZFoXO5l8mQSOUmH, accessed 09/30/2026, see position 196,819,314-196,837,159), and respective gene’s promoter, and encompasses a dsDNA vector, and comprise each homology arm of recited lengths and thus is not markedly different from a natural based product.
Regarding instant cl. 23, a delivery system, defined as “any substance or combination of substances that can be used to bring (deliver) a targeting vector a cell” (pg. 48, line 10-11), is broadly interpreted as sterile water or, even, a buffer, which is not an additional element that is sufficient to satisfy the significantly more requirement.
The judicial exception is not integrated into a practical application because the claims do not recite any more elements in addition to the judicial exception, such as, provide a modified form of the targeting vector that is markedly different from its naturally occurring counter-part. The term “exogenous” describes the process of transferring the sequence of interest and still encompasses, as defined in the specification, “transferred naturally to a host organism.” Further, a skilled artisan may test a naturally occurring but different sequence (i.e. one with a SNP) by inserting into a host, i.e., (a) transferring a SNP-containing sequence between the homologous arms or vice-versa (b) transferring a wild-type sequence between the homologous arms, even if transferred through genetic engineering. The new “exogenous” sequence with an SNP site or a wild-type sequence is not markedly different from its naturally occurring counterpart. Thus, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Thus, claims 1, 13-16, 18-19, 23 are rejected under 35 USC 101.
Response to Arguments
Applicant's arguments filed 07/31/2026 (“the Remarks”) have been fully considered but they are not persuasive.
The Remarks insist that amending the claim to “exogenous sequence of interest flanked by homology arms” overcomes the judicial exception (pg. 10). The Remarks point to the following language in the specification for support of exogenous: a “gene may be endogenous (occurring naturally in a host organism) or exogenous (transferred, naturally or through genetic engineering, to a host organism)” (pg. 39, line 25-27).
The argument is not persuasive.
As noted in the rejection, the term “exogenous” describes the process of transferring the sequence of interest and still encompasses, as defined in the specification, “transferred naturally to a host organism.” Further, a skilled artisan may test a naturally occurring but different sequence (i.e. one with a SNP) by inserting into a host, i.e., (a) transferring a SNP-containing sequence between the homologous arms or vice-versa (b) transferring a wild-type sequence between the homologous arms, even if transferred through genetic engineering. The new “exogenous” sequence with an SNP site or a wild-type sequence is not markedly different from its naturally occurring counterpart.
To be clear, the specification indicates that a vector can be a double-stranded DNA vector (pg. 2, line 28), which encompasses a chromosome as well. Thus, the rejection is maintained.
Claim Rejections - 35 USC § 102
Rejection of claims 1, 13-16, 18-19, 21, 23 under 102 in view of Skarnes is withdrawn due to claim amendment which narrows the safe harbor site of chromosome 1.
Rejection of claims 1, 13-16, 18, 21 under 102 in view of as being anticipated by Magali (2014, www.ensembl.info/2014/03/11/grch38-assembly-mapping-updating-coordinates-in-the-new-human-genome/#comments), as evidenced by 1q31 or Human_1 186000000-198000000, as an appendix to Magali, (see attachment “Human_1186000000_198000000”) is withdrawn due to claim amendment, but upon further consideration is rejected as noted below.
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.
(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 1, 13-16, 18, 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Magali (2014, www.ensembl.info/2014/03/11/grch38-assembly-mapping-updating-coordinates-in-the-new-human-genome/#comments, of record), as evidenced by 1q31.3 or Human_1: 193800001 – 198700000 (see attachment “genome.ucsc.edu-CHR1-1q31.3”, genome.ucsc.edu/cgi-bin/hgTracks?db=hg38&lastVirtModeType=default&lastVirtModeExtraState=&virtModeType=default&virtMode=0&nonVirtPosition=&position=chr1%3A193800001-198700000&hgsid=4183529437_9H2hgUOlIXCBGZFoXO5l8mQSOUmH, accessed 09/30/2026) and Gene Report of Complement factor H related 1 (CFHR1, GeneID: 3078, www.ncbi.nlm.nih.gov/gene/3078, accessed 09/30/2026), as appendices to Magali.
Here claim 1 recites “engineered nucleic acid targeting vector comprising an exogenous sequence of interest flanked by homology arms, each homology arm comprising a sequence homologous to a sequence in a safe harbor site in a human genome” in the claimed locus. The claim, under BRI, is interpreted to read on the claimed genome locus of the chromosome and as noted above, “exogenous” is described as “(transferred, naturally or through genetic engineering, to a host organism)” (pg. 39, lines 25-27), thus is interpreted on how the exogenous gene is transferred to a host.
Regarding instant cl. 1, Magali discloses that GRCh38 assembly for human was released in December 2013. The Genome Data Viewer provides the assembly of claimed coordinates, within the 1q31.3 region (as noted above in 112(b) rejection, the broader coordinate is used for rejections). The 1q31.1 region comprises the coordinate positions 193,800,001 to 198,700,000 of chromosome 1, which is the range of instant cl. 1, has any sequence of interest and a skilled artisan can define the flanking sequences of the sequence of interest as the homologous arms, which would comprise sequences homologous to claimed coordinates locus.
Regarding instant cl. 13-16, 18, 21, the coordinates corresponding to 1q31.3 comprise various open reading frames, including CFHR1 (GeneID:3078, pos. 196,819,314-196,837,159), comprises the sequence of promoter that expresses CFHR1, a gene of interest that encodes a full length protein (i.e. CFHR1) (relevant to instant cl. 13-16). A genome is double stranded (relevant to instant cl. 18). A ~20 nt. sequence of gRNA with a particular endonuclease-specific PAM sequence can be identified within the claimed region (relevant to instant cl. 21).
Response to Arguments
Applicant's arguments filed 07/31/26 (“the Remarks”) have been fully considered but they are not persuasive.
The Remarks traverse the 102 rejection in view of Magali based on following arguments:
Since Magali is a blog of “methodology of mapping genomic coordinates and gene annotations” and does not describe “constructing any vector, selecting any sequence of interest, or flanking any sequence with homology arms” and action’s proposal of “a skilled artisan can define the flanking sequences of the sequence of interest as the homologous arms” is a “hypothetical construction assembled by selecting an arbitrary 1kb segment (or transcript ENST000000658976.2” and then designating neighboring sequence “homology arms,” allegedly contravening Arkley’s holding (“after-the-fact selection and recombination of a reference’s disclosure”.
The argument is not persuasive.
The sequence of chromosome 1 is interpreted to encompass the claimed safe harbor site sequence.
Arkley states that “any need for picking, choosing, and combining various disclosures,” (underline added for emphasis). Arkley is noting that one cannot just pick any disclosures, i.e. references. But the Remarks state that Magali fails to anticipate the instant claims because one of ordinary skill would have to pick and choose particular sequences. This is not what Arkley is suggesting, Arkley suggests not choosing and picking references for a 102 rejection, not picking and choosing products. Second, the facts of Arkley are regarding whether the claimed product “cephaloridine” is ‘described’ in the Flynn patent and provides that to apply 102 that “the Flynn reference must clearly and unequivocally disclose the claimed compound.” The Arkley court held that Flynn described the precursors and did not disclose the claimed compound.
Unlike Arkley, Magali and its evidenced sequence disclose the complete chromosome 1 sequence and encompasses the claimed safe harbor site sequence, i.e. discloses the claimed compound, regardless what one calls (or “define[s]”) the sequence (i.e. “gRNA”, “homologous arms”) and no picking or choosing is required. Thus, Magali anticipates instant claims 1, 13-16, 18, 21.
Allowable Subject Matter
No claim allowed.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEYUR A. VYAS whose telephone number is (571)272-0924. The examiner can normally be reached M-F 9am - 4 pm (EST).
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/KEYUR A VYAS/Examiner, Art Unit 1637
/Jennifer Dunston/Supervisory Patent Examiner, Art Unit 1637
