DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Preliminary Amendment
1) Acknowledgment is made of Applicants’ preliminary amendment filed 09/15/2022.
Election
2) Acknowledgment is made of Applicants’ election filed 12/05/2025 in response to the species election requirement mailed 10/07/2025. Applicants have elected the L. fermentum and L. fermentum CECT5716 probiotic species and the D-glucose EPS species. Because Applicants did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (M.P.E.P § 818.03(a)).
Status of Claims
3) Claims 3-8, 10, 13-15, 22, 23, 28 and 22 have been amended via the preliminary amendment filed 09/15/2022.
Claims 1-28 are pending.
Claims 17 and 18 are withdrawn from consideration as being directed to a non-elected species. See 37 C.F.R 1.142(b) and M.P.E.P § 821.03.
Claims 1-16 and 19-28 are examined on the merits.
Drawings
4) Acknowledgment is made of Applicants’ drawings filed 09/15/2022.
Sequence Listing
5) Acknowledgment is made of Applicants’ Sequence Listing which has been entered on 09/08/22.
Priority
6) The instant AIA application, filed 09/15/2022, is the national stage 371 application of PCT/US2021/056471 filed 03/15/2021 and claims priority to the European application 20382195.4 filed 03/16/2020. A certified copy of the foreign priority application is of record.
Objection(s) to Specification & Claim(s)
7) The instant specification is objected to for the following reason(s):
(a) MPEP 601.01 (g) which states "if the drawings show Figures 1A, 1B, and 1C and the brief description of the drawings refers only to Figure 1, this is an error in the specification which must be corrected."
Figure 1 of the instant application include panels a), b), c), d), e) and f). Figures 2 and 5-8 include panels a) and b). Figures 3 and 4 include panels a), b) and c). The ‘Brief Description of the Drawings’ on pages 2-3 of the specification is objected to. While the actual drawings identify the Figures as Figures A, B and C, or Figures A and B, the ‘Brief Description of the Drawings’ does not refer to the figures, for example, as --Figures 2a)-- and 2b) and so on. Amendments to pages 2-3 of the specification are needed to reflect this. References to these Figures throughout the specification should be amended accordingly.
(b) The instant specification incorporates subject matter into the patent application by reference to a hyperlink “https”. For example, see page 8. However, attempts to incorporate subject matter into the patent application by reference to an active hyperlink and/or other forms of browser-executable code is considered to be an improper incorporation by reference. See MPEP 608.01. Such embedded active hyperlinks and/or other forms of browser-executable code therefore require deletion or replacement with the phrase --hypertext transfer protocol secure--. It is suggested that Applicants examine the whole specification for similar recitations and make necessary correction.
(c) 37 C.F.R 1.75(d)(1) provides, in part, that ‘the terms and phrases used in the claims must find clear support or antecedent basis in the description so that the meaning of the terms in the claims may be ascertainable by reference to the description’.
(i) While there is antecedent basis in the as-filed specification at lines 14-15 of page 19 for --at least 6 x 1012 CFU per gram of collagen--, the limitation in claim 14 “at least 6 x 1012 CFU per gram of collagen” lacks antecedent basis in the as-filed specification.
(ii) The limitation “Gardenerella vaginalis 5” in claim 27 lacks antecedent basis in the as-filed specification.
Rejection(s) under 35 U.S.C § 112(a) or (Pre-AIA ) First Paragraph
8) The following is a quotation 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 35 U.S.C. § 112 (pre-AIA ), first paragraph:
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 the invention.
9) Claims 1-16 and 19-28 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 claims contain 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 the (pre-AIA ), the Applicant. This is a written description rejection.
The purpose of the written description requirement is ‘to ensure that the inventor had possession, as of the filing date of the application relied on, of the specific subject matter later claimed by him.’ In re Edwards, 568 F.2d 1349, 1351-52, 196 USPQ 465, 467 (CCPA 1978). The analysis of whether the as-filed specification complies with the written description requirements calls for the Office to compare the scope of the claims with the scope of the description to determine whether Applicant has demonstrated possession of the full scope of the claimed invention at the time of the invention.
Claim 11 is drawn to a biomaterial comprising a collagen scaffold, generic probiotics, and exopolysaccharide (EPS), wherein the collagen scaffold comprises fibrils between 100 and 500 nm diameter and wherein the sugar content in the biomaterial with respect to the collagen content of the biomaterial is of at least 2% (w/w). Each of the claim limitations ‘probiotics’, ‘EPS’ and ‘collagen’ scaffold represent a very broad genus encompassing structurally variable species. The genus of ‘probiotics’ is so incredibly huge that it encompasses genetically, taxonomically and antigenically divergent bacterial and fungal probiotic species. Likewise, the genus ‘Lactobacillus’ in claim 19 is very large encompassing genetically and antigenically divergent species and strains of the Lactobacillus genus. While claim 13 is limited to type I collagen, claim 11 and the rest of the dependent claims are not. While the collagen scaffold in the biomaterial of claim 13 is required to be the collagen scaffold showing a 67 nm periodic staggered D-banding pattern, the one recited in claim 11 and encompassed by the rest of the dependent claims is not. What precise concentration is encompassed within the scope of the limitation “at least 6 x 1012 CFU” in claim 14 is not understood. While the EPS in claim 16 is required to be the elected D-glucose species, the EPS recited in claim 11 and encompassed by the rest of the dependent claims broadly encompasses a large number of EPS of divergent structure. Likewise, claim 1 is drawn to a method for preparing such a biomaterial comprising type I collagen, probiotics and exopolysaccharide, the method comprising steps i), ii) and iii) as claimed broadly. The same genus-species analysis as set forth supra for probiotic bacteria, collagen and EPS applies to the method claimed in claims 1-10, 19-21 and 28. The biomaterial of claim 28 is required to be a pharmaceutical composition. The claimed biomaterial genus has to have a therapeutic use in medicine as recited broadly and a use in the treatment of any vaginal infection including ones caused by bacteria genus, yeast genus, and protozoan parasite genus; or a use in the treatment of bacterial vaginosis, trichomonas vaginitis, candidiasis, and bacterial vaginosis caused by overgrowth of normal vagina flora selected from Gardnerella vaginalis 5 or Mobiluncus spp. However, a review of the instant specification indicates that, at the time of the invention, Applicant was not in possession of the variable genus and the full scope of the biomaterial as broadly claimed.
The written description requirement can be met by describing the claimed subject matter to a person skilled in the art using sufficiently detailed, relevant identifying characteristics such as functional characteristics, and correlating those functional characteristics with a disclosed structure. See Enzo Biochem v. Gen-Probe, 323 F.3d 956, 964, 967, 968 (Fed. Cir. 2002).
There is an inverse correlation between the level of predictability in the art and the amount of disclosure necessary to satisfy the written description requirement. The written description inquiry is case- and context-specific. It “depend[s] on the nature of the claimed invention and the knowledge of one skilled in the art at the time an invention is made and a patent application is filed.” Ariad, 560 at 1372. A number of factors guide the inquiry, including “the existing knowledge in the particular field, the extent and content of the prior art, the maturity of the science or technology, and the predictability of the aspect at issue.” Ariad, 560 at 1372. [Emphasis added]. According to MPEP 2163:
The description needed to satisfy the requirements of (pre-AIA ) 35 U.S.C § 112 “varies with the nature and scope of the invention at issue, and with the scientific and technologic knowledge already in existence.” Capon v. Eshhar, 418 F.3d at 1357, 76 USPQ2d at 1084. Patents and printed publications in the art should be relied upon to determine whether an art is mature and what the level of knowledge and skill is in the art.
Evidence required to demonstrate possession of the invention is fact-specific and varies inversely with the maturity and predictability of the technology area. Inventions in “unpredictable” arts are subject to greater scrutiny under the written description requirement, and require a greater showing of possession than more predictable arts. This is important in the instant application because the art recognizes strain-specificity and functional unpredictability associated with diverse probiotics. For example, Gao et al. (Peer J. 7: e7117, pages 1/24-24/24, 2019) taught that the probiotic effects are dependent on the nature of the strain by stating that “.... the efficacy ..... varies, depending on the types and strains of probiotics”. See third paragraph of page 2 of Gao et al. See also title; the 3rd full sentence of 1st full paragraph and the last full sentence of the paragraph bridging the two columns of page 6; and the last sentence under section ‘5. Conclusion’ of Fang et al. J. Function. Foods 60: 103426, pages 1-9, 2019. This clearly indicates that not all species and strains of bacterial probiotics encompassed within the broad scope of the recited probiotics genus or the recited probiotic bacteria genus can be predicted to be capable of broad use in medicine, use in the treatment of vaginosis caused by bacteria genus, yeast genus, and protozoan parasite genus, or use in treating bacterial vaginosis, trichomonas vaginitis, candidiasis, and bacterial vaginosis caused by overgrowth of normal vagina flora selected from Gardnerella vaginalis 5 or Mobiluncus spp. as claimed, when used as a biomaterial entrapped in a collagen matrix with a generic EPS as claimed. Furthermore, the as-filed specification indicates the specificity of certain conditions under which the steps of the claimed method are carried out, for example, the ratio of specific probiotic bacteria to type I collagen; and the pH of the monomeric collagen solution that is acidic enough so as to prevent the collagen for spontaneously associating into fibrils prior to step (ii) or prior to the contacting with the probiotic bacteria. The term ‘probiotics’ and ‘probiotic bacteria’ in instant claims encompass within their broad scope single probiotic species and more than one probiotic species. The as-filed specification expressly states that when more than one probiotic species is used, the probiotic composition does not comprise the strain Lactobacillus plantarum LMG P-21021-LP01, the strain Lactobacillus plantarum LMG P-21020 -LP02, the strain Lactobacillus fermentum DSM 26955 (LF15), or the strain Lactobacillus fermentum DSM 26956 (LF16). Clearly, at the time of the invention, other than a biocomposite comprising the specific probiotic bacterial species of L. fermentum such as L. fermentum CECT5716 or L. acidophilus CECT903 each entrapped in type I collagen matrix (col-Lf and col-La) scaffold comprising collagen fibrils of between 100 and 500 nm diameter and showing a 67 nm periodic staggered D-banding pattern and the specific EPS species of said Lf and La, prepared as described in instant Examples, Applicant was not in possession of the full scope of the entire biomaterial genus and of the method of preparing said genus as claimed broadly.
It must be noted that a mere idea or unsubstantiated function is insufficient for written description; characterization of a representative number of species in an unpredictable art, with their precise structure correlated with the requisite functions, is required in order to claim the broad genus. Capon v. Eshhar, 418 F.3d 1349 (Fed. Cir. 2005) states:
When a patent claims a genus using functional language to define a desired result, the specification must demonstrate that the applicant has made a generic invention that achieves the claimed result and do so by showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus.
In the instant application, a convincing structure-function correlation is lacking for a representative number and variety of species within the variant genus. The specification does not describe the claimed embodiments in sufficient detail to convey to a person skilled in the art that Applicant was in possession of each of the variant genus identified supra and the full scope of the claimed invention at the time of filing.
MPEP § 2163.02 states: ‘an objective standard for determining compliance with the written description requirement is, does the description clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed’. The courts have decided that the purpose of the ‘written description’ requirement is broader than to merely explain how to ‘make and use’; the applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed. See Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Federal Circuit, 1991). Furthermore, the written description provision of 35 U.S.C § 112(a) is severable from its enablement provision. Applicant should note that written description requires more than a mere statement that something is part of the invention and a reference to a potential method for isolating it. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. The specific description or guidance, not general description is needed. A mere idea or unsubstantiated function is insufficient for written description in an unpredictable art; a concrete structure-function correlation is required. Clearly, the instant specification does not describe the claimed invention in sufficient detail to convey to a person skilled in the art that Applicant was in possession of the full scope of the claimed invention at the time of filing. Instant claims do not meet the provision of 35 U.S.C § 112(a).
Rejection(s) under 35 U.S.C § 112(b) or (Pre-AIA ), Second Paragraph
11) 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.
12) Claims 1-16 and 19-28 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 inventor or a joint inventor, or for the pre-AIA the Applicant regards as the invention.
(a) Claim 1 is ambiguous and indefinite in the inconsistent recitation of “probiotics” (see lines 2 and 9) and “probiotic bacteria” (see lines 3, 6 and 7). The elements used in steps i) and iii) and obtained in step ii) are ‘probiotic bacteria’, yet the preamble of the claim states that the claimed method is for preparing a biomaterial comprising ‘probiotics’. Note that the two terms are of different scope, the former broader than the latter.
(b) Claim 1 is ambiguous and indefinite in the inconsistent recitation of “type I collagen” (see line 1) and “collagen ...” in steps 1), ii) and iii). The claimed method is for preparing a biomaterial comprising ‘type I collagen’, yet the method steps fail to specify that what is used therein is type I collagen. Note that the two terms are of different scope, the former narrower than the latter.
(c) Claim 1 is further ambiguous and indefinite in the inconsistent limitations within step iii), of “.... probiotic bacteria” and “the probiotics”. It is unclear how ‘probiotic bacteria’ of narrower scope that is maintained in line 1 of step iii) can form EPS by “the probiotics” of broader scope. One of ordinary skill cannot recognize in an unambiguous way that which is being claimed.
(d) Claim 1 is indefinite for lacking sufficient antecedence in the limitations “entrapped probiotic bacteria” (see line 7) and “EPS” (see line 9). For proper antecedence, it is suggested that Applicants insert the limitation –the-- prior to each of said limitations.
(e) Claim 4, dependent from claim 1, is indefinite for lacking sufficient antecedence in the limitation “collagen fibrils” (see line 2). For proper antecedence, it is suggested that Applicants insert the limitation –the-- prior to said limitation.
(f) Claim 6, dependent from claim 1, is indefinite in having an antecedence issue and an inconsistency issue with claim 1, in the limitation ‘entrapped probiotic’. Claim 1 from which claim 6 depends recites ‘entrapped probiotic bacteria’, but not ‘entrapped probiotic’. For the purpose of distinctly claiming the subject matter with proper antecedence, it is suggested that Applicant replace the above-identified limitation in claim 6 with the limitation --the entrapped probiotic bacteria--.
(g) Claim 2 is ambiguous and indefinite in having a confusing antecedence in the limitations: “the collagen” is type I collagen. Claim 2 depends from claim 1, which includes the recitations of ‘collagen monomers’, ‘collagen fibers’, and “type I collagen”. Where does the limitation “the collagen” in the dependent claim 2 derive its antecedence from is unclear. One of ordinary skill cannot recognize in an unambiguous way that which is being claimed. The metes and bounds of the claim are indeterminate.
(h) Claims 9 and 21 are ambiguous and indefinite in the use of the limitation ‘particularly’, which renders anything behind the limitation only optional. Said particular feature does not have any limiting effect within the scope of the claims. The scope of the claims are unascertainable. See MPEP § 2173.05(d).
(i) Claim 14 is ambiguous, incorrect and/or indefinite in the limitation “at least 6 x 1012 CFU”. It is unclear what precise CFU does it represent. One of ordinary skill cannot recognize in an unambiguous way that which is being claimed.
(j) Claim 10 is indefinite for lacking sufficient antecedence in the limitation “a method” of claim 1. For proper antecedence, it is suggested that Applicant replace said limitation with --the method-- of claim 1.
(k) Claim 13 is ambiguous and indefinite in having an antecedence issue with regard to the limitation “the collagen”. Claim 13 depends from claim 11, which includes the recitation of “a collagen scaffold”, but not of ‘a collagen’.
(l) Claims 1, 6-8, 19 and 21 include inconsistent recitations of varying scope and confusing antecedence such as “probiotics”, “probiotic bacteria”, “probiotic”, “the probiotics” and “the probiotic” and render the metes and bounds of the claims indeterminate.
(m) Analogous rejection applies to claims 11 and 14 with regard to the inconsistent recitations of varying scope such as “probiotics” and “the probiotic”.
(n) Claim 6 is ambiguous and indefinite in the abbreviated limitation “MRS” because it is unclear what does it represent or encompass contents-wise. It is suggested that Applicant recite the specific full terminology with the abbreviation retained within parentheses.
(o) The dependent claim 9 is indefinite for lacking sufficient antecedence in the limitation “Method according to claim 8”. For proper antecedence, it is suggested that Applicant replace said limitation with --The method according to claim 8--.
(p) The independent claim 11 is indefinite for having improper antecedence in the limitation “the sugar .....”. See line 3.
(q) Claim 27 is vague and indefinite in the limitation “Gardenerella vaginalis 5”. It is unclear what does “5” within said limitation mean. Is the recited “5” the number assigned to the recited Gardenerella vaginalis? One of ordinary skill cannot recognize in an unambiguous way that which is being claimed.
(r) Claims 2-10, 19-21 and 28, which depend directly or indirectly from claim 1, and claims 12-18 and 22-27, which depend directly or indirectly from claim 11, are also rejected as being indefinite due to the indefiniteness identified supra in the base claim.
Rejection(s) under 35 U.S.C § 112(d) or (Pre-AIA ), Fourth Paragraph
13) The following is a quotation of 35 U.S.C. § 112(d):
(d) REFERENCE IN DEPENDENT FORMS. - Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. § 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
14) Claim 2 is rejected under 35 U.S.C § 112(d) or pre-AIA 35 U.S.C § 112, fourth paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
The dependent claim 2 fails to further limit the subject matter of claim 1 from which it depends with regard to the limitation “the collagen is type I collagen”. The base claim 1 includes the recitation of “type I collagen” and claim 2 which depends from claim 1 is not further limiting. Applicant may cancel the claim, or present a sufficient showing that the dependent claim complies with the statutory requirements.
Relevant Art
15) The art made of record and not relied upon in any of the rejections is considered pertinent to Applicant’s disclosure:
The following references in the art document that L. fermentum CECT5716 is a well-characterized, art-known probiotic strain:
l EFSA Panel. Scientific Opinion on the Lactobacillus fermentum CECT 5716 and a reduction of the Staphylococcus load in breast milk which reduces the risk of infectious mastitis: evaluation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006. EFSA Journal 15(7): 4917, 1-13, 24 July 2017:
EFSA Panel (2017) taught the following indicating that the Lactobacillus fermentum CECT 5716 is an art-known strain well characterized by multiple groups of scientists:
3.1. Assessment Characterisation of the food/constituent.
The food/constituent that is the subject of the health claim is Lactobacillus fermentum CECT 5716. The species and strain identity and the characteristics of L. fermentum CECT 5716 have been determined using phenotypic and genotypic methods as indicated in the references provided (Martin et al., 2003, 2005; Xaus et al., 2003). The whole genome of L. fermentum CECT 5716 has been sequenced (Jimenez et al., 2010).
A culture collection number from the Spanish Type Culture Collection (CECT) is indicated ....... International Depositary Authority under the Budapest Treaty.
The Panel considers that the food/constituent Lactobacillus fermentum CECT 5716, which is the subject of the health claim, is sufficiently characterized.
l Rodriguez-Sojo et al. (Nutrients 13: 1106, pages 1/22 to 22/22, 2021) teach the following (see section 2.1 on page 4 of 22; and Table 3):
L. fermentum CECT5716 is a probiotic strain initially isolated from the human breast
milk of healthy mothers, and for over 15 years, it has been included in nutrition supplements and fermented milk products [23]. ............ the genome of L. fermentum CECT5716 is composed of 2100449 bp and contains 1109 protein encoding genes, 54 tRNA encoding genes, and 20 rRNA encoding genes.
l Jimenez et al. (J. Bacteriol. 192 (18): 4800, 2010) taught that the Lactobacillus fermentum CECT 5716 is a well-characterized probiotic strain isolated from human milk and is used at present in commercial infant formulas. Jimenez et al. reported the complete and annotated genome sequence of this strain. See Abstract.
l López-Huertas E (Benef. Microbes. 6(2): 219-224, 2015) taught the safety and efficacy of human breast milk Lactobacillus fermentum CECT 5716. See title and Abstract.
l Ozen et al. (Nutrients15(9):2207, 06 May 2023) reported on the clinical potential of Lactobacillus fermentum CECT 5716, also known as Limosilactobacillus fermentum CECT 5716. Ozen et al. taught that Limosilactobacillus fermentum (L. fermentum) CECT5716, isolated from HM, is a well-known strain in the fields of nutritional research and consumer health. See entire reference including title; last full paragraph under ‘Introduction’.
l Olivares et al. (Nutrition 23:254-260, 2007) taught that oral intake of Lactobacillus fermentum CECT5716 enhances the effects of influenza vaccination.
Claim(s) Objections - Suggestion(s)
16) Claims 7, 20, 24 and 27 are objected to for the following reasons:
(a) Claims 7 (see line 2) and 20 (see line 1) are objected to for the non-italicized recitation of ‘Lactobacillus’. To be consistent with the practice in the art of scientific nomenclature of bacteria and with the correct form used in line 2 of claim 19, it is suggested that Applicant delete each of the above-identified limitation via strikethrough, for example, Lactobacillus and replace with the italicized limitation –Lactobacillus-- with underlining.
(b) Analogous objection applies to claim 27 with regard to the limitation “Mobiluncus” spp..
(c) The limitation “The Method” in line 1 of claim 7 must be changed to --The method--.
(d) Claim 24 is incorrect in the recitation of the plural “bacteria” in association with the verb “is”.
(e) Claim 20 is objected for the confusing limitation “from 8.” In line 3 of the claim.
Conclusion
17) No claims are allowed.
Correspondence
18) Any inquiry concerning this communication or earlier communications from the Examiner should be directed to S. Devi, Ph.D., whose telephone number is (571) 272-0854. A message may be left on the Examiner’s voice mail system. The Examiner is on a flexible work schedule, however she can normally be reached Monday to Friday from 8.00 a.m. to 4.00 p.m. (EST). If attempts to reach the Examiner by telephone are unsuccessful, Examiner's Supervisor, Daniel E. Kolker, can be reached at (571) 272-3181. The fax phone number for the organization where this application or proceeding is assigned (571) 273-8300.
19) Information regarding the status of an application may be obtained from Patent Center. Status information for unpublished applications is available through Patent Center or Private PAIR to authorized users only. Should you have questions about access to Patent Center or the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, Applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
/S. DEVI/
S. Devi, Ph.D.Primary Examiner
Art Unit 1645
February, 2026
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