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 elected Invention II (claims 29-36), without traverse, in the reply filed on 11/07/2025.
Claims 1-28 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Accordingly, claims 29-36 have been examined on the merits.
Priority
The instant application claims the priority benefit of U.S. Provisional Application No. 63/366150 (filed on 6/10/2022) under 35 U.S.C. 119(e).
Drawings
The drawings are objected to because the chart is illegible. 37 C.F.R. 1.84 section (l) states “All drawings must be made by a process which will give them satisfactory reproduction characteristics. Every line, number, and letter must be durable, clean, black (except for color drawings), sufficiently dense and dark, and uniformly thick and well-defined. The weight of all lines and letters must be heavy enough to permit adequate reproduction.” See MPEP § 608.02(V).
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.
In addition to Replacement Sheets containing the corrected drawing figure(s), applicant is required to submit a marked-up copy of each Replacement Sheet including annotations indicating the changes made to the previous version. The marked-up copy must be clearly labeled as “Annotated Sheets” and must be presented in the amendment or remarks section that explains the change(s) to the drawings. See 37 CFR 1.121(d)(1). Failure to timely submit the proposed drawing and marked-up copy will result in the abandonment of the application.
Claim Objection (Warning)
Applicant is advised that should claim 29 be found allowable, claim 34 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 101
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 29-36 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a law of nature and natural phenomenon without significantly more.
The United States Patent and Trademark Office (USPTO) issued a revised guidance for evaluating subject matter eligibility, referred to as “2019 Revised Patent Subject Matter Eligibility Guidance”, which became effective on January 7, 2019 (see 84 Fed. Reg. 50) and updated on October 2019 and July 2024. In the instant application, claims 29-36 recite a law of nature and natural phenomenon. This judicial exception is not integrated into a practical application, and the claims do not include additional elements that are sufficient to amount to significantly more than said judicial exception as explained below:
Subject Matter Eligibility Guidance
A three-step inquiry has been established to determine subject matter eligibility under 35 U.S.C. 101, in accordance with MPEP 2106:
Step (1). Is the claim directed to a process, machine, manufacture, or composition of matter?
Step (2A). Is the claim directed to a law of nature, natural phenomenon (product of nature), or an abstract idea?
Prong 1 – Does the claim recite a law of nature, natural phenomenon, or an abstract idea?
Prong 2 – If the claim recites a judicial exception, does it recite additional elements that integrate the judicial exception into a practical application? Limitations that are indicative of integration into a practical application include:
Improvements to the functioning of a computer, or to any other technology or technical field. See MPEP 2106.05(a)
Applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition. See Vanda Memo
Applying the judicial exception with, or by use of, a particular machine. See MPEP 2106.05(b)
Effecting a transformation or reduction of a particular article to a different state or thing. See MPEP 2106.05(c)
Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. See MPEP 2106.05(e) and Vanda Memo.
Step (2B). If the recited judicial exception is not integrated into a practical application, does the claim recite additional elements that amount to significantly different than the judicial exception such that they provide an inventive concept? This step includes evaluation of the same considerations under Step (2A), Prong 2, as well as two additional considerations:
Adding a specific limitation or combination of limitations that are not well-understood, routine, conventional activity in the field, which is indicative that an inventive concept may be present; and
Simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, which is indicative that an inventive concept may not be present.
Analysis in View of the Interim Guidance
The answer to Step (1) is “yes” since the claims are directed to a product, which is a statutory category.
The answer to Step (2A) is “yes” because the claimed product is directed to a law of nature and natural phenomenon, specifically a natural product.
Prong 1: Claim 29 is drawn to a “combination”, while claims 30 and 35 are drawn to a “kit” comprising said combination and a “multi-compartment container” comprising the components in different compartments, respectively. The term “combination” is considered by the examiner to be not identical to the term “composition” (as in claim 34) because the parts/components are interpreted to be not necessarily mixed together.
The claims recite that one of the components of the combination is “a soluble hyaluronidase”. Hyaluronidase is naturally soluble and is naturally produced by various microorganisms and animals such as humans. It is noted that cabotegravir and the hyaluronidase are specified to be in separate compositions or in separate compartments in claims 31, 33, and 35-36. The recited natural product, soluble hyaluronidase, is therefore provided on its own. Thus, the claimed combination, kit, and multi-compartment container are considered nature-based products.
Claims also recite that another component is “a suspension comprising cabotegravir”. Cabotegravir is a synthetic antiretroviral drug and does not exist naturally together with a soluble hyaluronidase. Although claims 32 and 34 require that cabotegravir is co-formulated or in a composition with soluble hyaluronidase, the disclosure does not show that combining them results in a significant change in the natural product’s structure, property, or function.
Prong 2: Providing the soluble hyaluronidase as part of a kit or in a multi-compartment container does not induce a transformation or reduction to a different state or thing. It also does limit the soluble hyaluronidase to a particular field of use. Thus, there are no additional elements that integrate the recited judicial exception into a practical application.
The answer to Step (2B) is “no”. Formulating the soluble hyaluronidase with a therapeutic agent as a combination and providing it as part of a kit is known and conventional in the field. For example, Vesole et al. (WO 2022/109555 A1) teaches a combined preparation comprising a hyaluronidase and rilpivirine which can be combined with other antiretroviral drugs like cabotegravir, as well as a kit comprising said materials (lines 20-26, page 5; lines 1-10, page 44).
Hence, claims 29-36 do not qualify as eligible subject matter.
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)(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 29-32 and 34 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Vesole et al. (Pub. No. WO 2022/109555 A1).
Vesole et al. discloses products containing a hyaluronidase and rilpivirine or a pharmaceutically acceptable salt thereof as a combined preparation for simultaneous or sequential use in the treatment or prevention of HIV infection by intramuscular or subcutaneous injection (lines 22-25, page 4; lines 20-23, page 5). It also provides a kit of parts comprising a hyaluronidase and rilpivirine or pharmaceutically acceptable salt thereof (lines 30-31, page 4; lines 25-26, page 5).
According to Vesole et al., hyaluronidase degrades hyaluronic acid and lowers the viscosity of hyaluronan in the extracellular matrix. It can therefore be used to increase dispersion and absorption of injected active pharmaceutical ingredients (lines 3-5, page 26). When the active pharmaceutical ingredient is administered in high volumes that can cause bump formation at injection sites, administering it with hyaluronidase can reduce such bump formation (lines 13-16, page 26).
Preferably, the hyaluronidase is recombinant human hyaluronidase (rHuPH20; CAS registry no. 757971-58-7) (lines 21-26, page 26). The hyaluronidase can be formulated as a solution in a separate pharmaceutical composition, i.e., without the rilpiverine (lines 9-11, page 30). Similarly, the rilpiverine or pharmaceutically acceptable salt thereof can be provided in a separate pharmaceutical composition from the hyaluronidase (lines 23-25, page 18).
In some embodiments, the disclosed products or kit of parts is used in combination with one or more other antiretroviral agents like cabotegravir, in particular as an injectable micro- or nanosuspension (lines 1-9, page 44). The one or more other antiretroviral agent can be administered simultaneously or sequentially with the hyaluronidase and rilpiverine (lines 19-21, page 44). For example, the hyaluronidase is administered first, followed by cabotegravir, and then followed by the rilpivirine or a pharmaceutically acceptable salt thereof (lines 21-33, page 44).
Vesole et al. reads on the instant application’s combination/composition and kit as follows:
Regarding claims 29 and 34: The embodiment of the disclosed products in combination with one or more other antiretroviral agents like cabotegravir as an injectable micro- or nanosuspension is identical to “A combination” and “A composition” comprising “a suspension comprising cabotegravir”.
The preferred hyaluronidase in the disclosed products being rHuPH20 such as the one disclosed in the publication WO 2004/078140 (lines 21-26, page 26), which is a soluble hyaluronidase, is the same as “a soluble hyaluronidase”.
Regarding claim 30: the kit comprising the hyaluronidase-containing product in combination with one or more other antiretroviral agents like cabotegravir corresponds to “A kit, comprising the combination of claim 29”.
Regarding claim 31: the cabotegravir being administered sequentially suggests that it is provided separately from the products comprising hyaluronidase, which meets “wherein the hyaluronidase and cabotegravir are in separate compositions”.
Regarding claim 32: the cabotegravir being administered simultaneously with the hyaluronidase-containing products indicates they are mixed together, thereby satisfying “wherein the hyaluronidase and cabotegravir are co-formulated”.
Claim Rejections - 35 USC § 103
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.
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 29-36 are rejected under 35 U.S.C. 103 as being unpatentable over Vesole et al. (Pub. No. WO 2022/109555 A1) in view of Xiaoming et al. (Pub. No. EP 2907504 A1).
The teachings of Vesole et al. are set forth above and applied herein. Vesole et al. is found to anticipate claims 29-32 and 34.
Vesole et al. is comparable to the claims below:
Regarding claim 33: the hyaluronidase and cabotegravir in the combination of claim 29 are further required to be “in separate compositions in a container with at least two compartments”.
Vesole et al. is different from the instant claim in that the one or more other antiretroviral agents like cabotegravir and the disclosed products comprising hyaluronidase are provided as separate formulations, but are not explicitly taught to be placed in a container having at least two compartments.
Nonetheless, such container is known and routinely used in the art. Xiaoming et al., for instance, teaches packaging materials for pharmaceutical products including vials, containers, and syringes (par. [0364]). One example of such packaging materials is an apparatus in the form of a dual- or multi-chamber container. Xiaoming et al. teaches that this type of apparatus has at least two chambers or compartments that maintain a hyaluronan-degrading enzyme separate from therapeutic agents (par. [0369]-[0371]).
Since Vesole et al. teaches that the disclosed hyaluronidase-products can be formulated and administered separately from the one or more other antiretroviral agents like an injectable micro- or nanosuspension of cabotegravir, it would have been obvious for a person with ordinary skill in the art before the effective filing date of the claimed invention to package said products and antiretroviral agents in a multi-chamber container, with each one of them placed separately in the container’s chambers or compartments, because it would keep them separate until use. Obviousness is based on the rationale that all claimed elements were known in the prior art and their combination would have yielded nothing more than predictable results. See MPEP § 2143 and KSR, 550 U.S. 398, 82 USPQ2d at 1395; Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976).
Claim 33 is therefore obvious over Vesole et al. in view of Xiaoming et al..
Regarding claim 35: the dual- or multi-chamber container of Vesole et al. and Xiaoming et al. comprising at least two chambers or compartments is analogous to “A multi-compartment container”.
The antiretroviral agent such as an injectable suspension of cabotegravir being placed in one of the at least two chambers or containers fulfills “a suspension comprising cabotegravir in one compartment”.
The disclosed products comprising hyaluronidase such as soluble hyaluronidase in another one of the at least two chambers or containers meets “a soluble hyaluronidase in a second compartment”.
Regarding claim 36: exemplary dual- or multi-chamber containers include dual chamber syringes (par. [0370]), which satisfy the requirement that the claimed multi-compartment container of claim 35 is “a syringe, comprising two compartments”.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHELLE F PAGUIO FRISING whose telephone number is (571)272-6224. The examiner can normally be reached Monday-Friday, 8:00 a.m. - 4:00 p.m..
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, Melenie L. Gordon can be reached at (571) 272-8037. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Michelle F. Paguio Frising/Primary Examiner, Art Unit 1651