DETAILED CORRESPONDENCE
Application Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Applicants’ amendment to the claims filed on 05/18/2026 in response to the Restriction Requirement mailed on 05/18/2026 is acknowledged. This listing of claims replaces all prior listings of claims in the application.
3. Claims 1-16 and 33 are cancelled.
4. New claims 41-58 are added.
5. Claims 17-18 and 41-58 are pending.
Election/Restrictions
6. Applicant’s election without traverse of Group II, claims 17-18 in the reply filed on 05/18/2026 is acknowledged.
7. Claims 17-18 and 41-58 are pending and examined on the merits.
Priority
8. Acknowledgement is made of applicants’ claimed domestic priority to U.S. Provisional Application No. 63/243882, filed on 09/14/2021.
Information Disclosure Statement
9. The IDSs filed on 02/19/2025 and 07/24/2026 have been considered by the examiner and copies of the Form PTO/SB/08 are attached to the office action.
Nucleotide and/or Amino Acid Sequence Disclosures
Summary of Requirements for Patent Applications Filed On Or After July 1, 2022, That Have Sequence Disclosures
37 CFR 1.831(a) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.831(b) must contain a “Sequence Listing XML”, as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.831-1.835. This “Sequence Listing XML” part of the disclosure may be submitted:
1. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter “Legal Framework”) in XML format, together with an incorporation by reference statement of the material in the XML file in a separate paragraph of the specification (an incorporation by reference paragraph) as required by 37 CFR 1.835(a)(2) or 1.835(b)(2) identifying:
a. the name of the XML file
b. the date of creation; and
c. the size of the XML file in bytes; or
2. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation by reference statement of the material in the XML format according to 37 CFR 1.52(e)(8) and 37 CFR 1.835(a)(2) or 1.835(b)(2) in a separate paragraph of the specification identifying:
a. the name of the XML file;
b. the date of creation; and
c. the size of the XML file in bytes.
SPECIFIC DEFICIENCIES AND THE REQUIRED RESPONSE TO THIS NOTICE ARE AS FOLLOWS:
Specific deficiency - This application fails to comply with the requirements of 37 CFR 1.831-1.834 because it does not contain a “Sequence Listing XML” as a separate part of the disclosure. A “Sequence Listing XML” is required because there are sequences listed in the Drawings and Specification that are encompassed by the definition of a nucleotide and/or amino acid sequence.
Required response - Applicant must provide:
• A “Sequence Listing XML” part of the disclosure, as described above in item 1. or 2.; together with
o A statement that indicates the basis for the amendment, with specific references to particular parts of the application as originally filed, as required by 37 CFR 1.835(a)(3);
o A statement that the “Sequence Listing XML” includes no new matter as required by 37 CFR 1.835(a)(4)
AND
• A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required incorporation by reference paragraph as required by 37 CFR 1.835(a)(2), consisting of:
o A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
o A copy of the amended specification without markings (clean version); and
o A statement that the substitute specification contains no new matter.
Claim Rejections - 35 USC § 112(b)
10. 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.
11. Claims 41-50, 52, and 54-55 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.
Regarding claims 41-50, 52 and 54-55, the term "about" is a relative term which renders the claim indefinite. The term "about" is a term of degree and the examiner has reviewed the specification and can find no examples or teachings that can be used for ascertaining the variance intended by the recited term of degree. Moreover, there is nothing in the specification or prior art of record to indicate that one of ordinary skill in the art could have ascertain the scope of the recited degree. It is suggested that applicant clarify the meaning of the claims. See Supplementary Examination Guidelines for Determining Compliance with 35 U.S.C. §112 and for Treatment of Related Issues in Patent Applications, 76 FR 7162 (Feb. 9, 2011), page 7165.
Claim Rejections - 35 USC § 102
12. 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.
13. Claim(s) 17-18 and 41-58 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Teschner et al. (US Patent Application Publication 2011/0066111 A1; cited on IDS filed on 02/19/2025).
14. Claims 17-18 and 41-58 are drawn to a method of subcutaneously infusing IgG to a subject in need thereof, the method comprising: (a) subcutaneously infusing a first amount of a pharmaceutical formulation of hyaluronidase to a first infusion site on the subject; and (b) following infusion of the first amount the pharmaceutical formulation of hyaluronidase, subcutaneously infusing a first amount of a pharmaceutical formulation of 20% (w/v) IgG to the first infusion site.
15. With respect to claim 17, Teschner et al. teach a method of subcutaneously infusing IgG to a subject in need thereof, the method comprising subcutaneously infusing a pharmaceutical formulation of hyaluronidase to a first infusion site on the subject and following infusion of the first amount of hyaluronidase, subcutaneously infusing a first amount of a pharmaceutical formulation of 20% (w/v) IgG to the first infusion site [see Abstract; paragraphs 0018, 0197, 0324, 0326, 0355-0358, Example 7; Table 45].
With respect to claim 18, Teschner et al. teach the method further comprising subcutaneously infusing a second amount of the pharmaceutical formulation to a second infusion site on the subject and following infusion of the second amount of the hyaluronidase, subcutaneously infusing a second amount of the pharmaceutical formulation of IgG to the second infusion site [see Abstract; paragraphs 0355-0358].
With respect to claim 41, Teschner et al. teach the method wherein the first amount of the pharmaceutical formulation of 20% (w/v) IgG is at least about 120 mL [see paragraph 0197].
With respect to claim 42-45 and 47, Teschner et al. teach the method wherein the infusion of the first amount comprises infusing at an infusion rate of 120 mL/hr, 240 mL/hr, or 300 mL/hr [see paragraphs 0355-0358].
With respect to claim 46, Teschner et al. teach the method wherein the first amount of the pharmaceutical formulation of 20% (w/v) IgG is at least about 120 mL [see paragraph 0197], and wherein the infusion of the first amount comprises infusing at an infusion rate of 120 mL/hr, 240 mL/hr, or 300 mL/hr [see paragraphs 0355-0358].
With respect to claim 48, Teschner et al. teach the method wherein the infusion of the first amount of the 20% IgG comprises infusing at least about 60% of the first amount of the pharmaceutical formulation of 20% (w/v) IgG at an infusion rate of 120 mL/hr, 240 mL/hr, or 300 mL/hr [see Abstract; paragraphs 0018, 0197, 0324, 0326, 0355-0357, Example 7; Table 45].
With respect to claim 49, Teschner et al. teach the method wherein the first amount of the pharmaceutical formulation of 20% (w/v) IgG is 200 mL to 300 mL [see paragraph 0197].
With respect to claim 50, Teschner et al. teach the method wherein the infusion of the second amount comprises infusing at an infusion rate of 120 mL/hr, 240 mL/hr, or 300 mL/hr [see paragraphs 0355-0358].
With respect to claim 51, Teschner et al. teach the method wherein the first amount of the pharmaceutical formulation of hyaluronidase is essentially similar between the method of infusing the pharmaceutical formulation of 20% IgG, and a method of infusing an otherwise identical pharmaceutical formulation containing 10% IgG [see Abstract; paragraphs 0018, 0197, 0324, 0326, 0355-0358, Example 7; Table 45].
With respect to claim 52, Teschner et al. teach the method wherein the first amount of the pharmaceutical formulation of 20% IgG is infused to the first infusion site at an infusion rate of 120 mL/hr, 240 mL/hr, or 300 mL/hr [see paragraphs 0355-0358] than that for infusing a pharmaceutical formulation of 20% IgG in the absence of the infusing of the first infusion site of the pharmaceutical formulation of hyaluronidase prior to the infusing the pharmaceutical formulation of 20% IgG to the first infusion site [see Abstract; paragraphs 0018, 0197, 0324, 0326, 0355-0358, Example 7; Table 45].
With respect to claim 53, Teschner et al. teach the method wherein the hyaluronidase is rHuPH20 [see paragraph 0201].
With respect to claim 54, Teschner et al. teach the method comprising subcutaneously infusing from about 50 U/g to about 10U/g IgG of hyaluronidase [see paragraph 0330].
With respect to claim 55, Teschner et al. teach the method comprising subcutaneously infusing 80 U/g IgG of hyaluronidase [see paragraph 0330].
With respect to claims 56-58, Teschner et al. teach the method wherein doses of 0.3 g/kg to 0.5 g/kg is infuses with formulations that are stable at room temperature for 6 months and refrigerator for 1-2 years (interpreted as unwarmed and warmed) [see Abstract; paragraphs 0018, 0197, 0324, 0326, 0355-0358, Example 7; Table 45].
Conclusion
16. Status of the claims:
Claims 17-18 and 41-58 are pending.
Claims 17-18 and 41-58 are rejected.
No claims are in condition for an allowance.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL J HOLLAND whose telephone number is (571)270-3537. The examiner can normally be reached Monday to Friday from 8AM to 5PM.
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.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Manjunath Rao can be reached at 571-272-0939. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PAUL J HOLLAND/Primary Examiner, Art Unit 1656
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