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 .
Response to Amendment
The Amendment filed 10/24/2025 has been entered. Applicant’s amendments are in response to in the Non-Final Office Action mailed 08/01/2025. Applicant’s claims have been amended in the following manner: independent claim 1 now specifies a “particle” to draw a new ground of rejection, and new claims 76-77 have been entered. With respect to Applicant’s argument concerning the Examiner’s position on claim 2, the Examiner’s finds the argument persuasive. Thus, a new rejection is issued in this second Non-Final Office Action, which includes Shenoy to address claim 2. Furthermore, claim 2 (including dependent claims) is addressed with respect to written description and indefiniteness.
The Examiner further acknowledges the following:
Claims 1-3, 5-6, 8-9, 11, 13, 17, 19-21, 23-24, 32-33, 35-37, and 76-77 are pending.
Claims 1-3, 5-6, 8-9, 11, 13, 17, 19-21, 23-24, 32-33, 35-37, and 76-77 are presented for examination and rejected as set forth below.
Claim Rejections - 35 USC § 112
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 2, 5-6, and 76 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.
The phrase (“otherwise essentially identical conditions”) in claim 2 is a relative term which renders the claim indefinite. The term “otherwise essentially identical conditions” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. On page 38 of the Specification, “essentially otherwise identical” can mean “within 5%, within 2 %, within 1%, or closer”, such that the parameters are variable and so the metes and bounds of the limitation are not well defined. Furthermore, it is unclear if additional ingredients are considered under “otherwise essentially identical conditions” (where the Specification states that “certain aspect of compositions described therein, such as encapsulation by a carrier material (e.g., a hydrogel) incorporate exemplary language and cannot be relied on to define the meaning of “otherwise essentially identical conditions”), or if it only particularly emphasizes the specific concentration of crystalline polypeptide. Thus, the phrase “otherwise essentially identical conditions” is indefinite and should be more precisely defined for consideration as a limitation.
Claim 2 recites the limitation “crystals” and “polypeptide” and “crystalline polypeptides, but the relationship between these materials is not readily apparent. There is insufficient antecedent basis for this limitation in the claim. The Examiner has addressed the claim as written assuming a relationship between “polypeptide” and “crystalline polypeptides”.
Additionally claims 5-6, and 76 are rejected for depending from claim 2.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-3, 5-6, 8-9, 11, 13, 17, 19-21, 23-24, 32-33, 35-37, and 76-77 are rejected under 35 U.S.C. 103 as being unpatentable over Chandrashekhar (US20020151650A1), and in further view of Yang (PNAS, 2003; cited on the IDS filed 05/25/2023), Ickenstein (Therapeutic Delivery, 2018), and Shenoy (US20180333493A1).
Applicant’s claims (independent claim 1) are directed to a composition, comprising a hydrogel particle and a crystal comprising the solid form of a polypeptide at least partially encapsulated by the hydrogel particle. Independent claims 2 and 3 attempt to limit this general concept from a different frame of reference by employing alternate limitations. Thus, the compositions of independent claims 1-3 are examined together, since they embody similar concepts for compactness of prosecution. Further note, the Examiner considers the descriptor “hydrogel” to have limiting weight, as it is a term of the art that suggests a biphasic material formulation with attributable structure (in contrast to a solution or suspension form), often having a “gel-like” appearance.
Note that claims 1-3 appear very broad, and the broadest reasonable interpretation will be taken for each. Furthermore, any expectation of unexpected results to break the obviousness of a rejection must be commensurate in scope with the claim language. In this case, the claim language appears far broader than the teachings of the examples of the Specification. Any reliance on unexpected results to demonstrate non-obviousness should meet the breadth of the instant claim scope.
Further note that claim 2 compares “a composition, comprising: crystals comprising a solid form of a polypeptide” to “an aqueous suspension having equivalent concentration of crystalline polypeptides under otherwise essentially identical conditions.” The indefiniteness of “otherwise essentially identical conditions” has been discussed in the 112 section. Thus, the only apparent distinguishing feature is a recitation of a “composition” verses as “suspension”, wherein a suspension is a type of composition. Thus, the Examiner has looked for Art that demonstrates any composition (which could be a suspension) that has a reduction in viscosity compared to any suspension.
Additionally, the Examiner has noted the very specific method of making that relies a specific centrifugal extrusion process (Example 6, figure 25). See Examples 2 and 3 (on pg 60 of the Specification) for an illustrative example of the manufacturing process. Also, “crystal comprising a solid form of a polypeptide” is understood to include species such as complexes (e.g., solid form of pembrolizumab complexed to caffeine as on pg 5 of the Specification, lines 16-19). The hydrogel particles are discussed, for example, in terms of microspheres (pg 3, Specification pg 9-10, pg 52, ‘conclusions’) and polymers such as polysaccharides, polyalkylene oxides, etc. (pg 2-3).
Chandrashekhar teaches gels that comprises an antibody [0064], for the use of drug delivery (abstract).
Regarding claim 1, 3, 5-6, 8, 33, and 35: Chandrashekhar teaches a gel (reads on hydrogel) that comprises an antibody [0064], useful for therapeutics (abstract). Chandrashekhar teaches macromers that are covalently or non-covalently crosslinkable to form hydrogels, such that the macromers are provided in a carrier [0025]. The bioactive molecules are encapsulated to achieve sustained drug release [0025, 0139].
Regarding claim 9: Chandrashekhar teaches polymer chains of at least 4000 Daltons (i.e., the polymer can be more than 4 kDa) [0030], where the initial polymer molecular weight influences degradation rate, suggesting room for optimization [0056].
Regarding claims 11, 13, and 17: Chandrashekhar teaches cross-linked polyalkylene oxides, polysaccharides, and polypeptides [0025, 0040].
Regarding claims 19-21 and 23-24: Chandrashekhar teaches that the macromers of the gel can form microspheres that generally have a diameter from the nanometer range to 5 mm [0071]. Note that "[A] prior art reference that discloses a range encompassing a somewhat narrower claimed range is sufficient to establish a prima facie case of obviousness." In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003) (see 2144.05(I)).
In summary, Chandrashekhar teaches antibody proteins encapsulated in hydrogel particles. However, Chandrashekhar does not explicitly teach incorporation of “a crystal comprising a solid form of a polypeptide” (instant claim 1), the effect where the dynamic viscosity is lowered between a composition and an aqueous suspension (instant claim 2), low (<10 wt%) aggregation (instant claim 3), low dynamic viscosity (instant claim 32), and the specified antibody type (instant claims 36-37).
Yang teaches a composition comprising crystalline monoclonal antibodies for subcutaneous delivery (abstract). Yang further teaches that crystalline monoclonal antibodies (mAbs) overcome the issues of high viscosity, aggregation, and poor stability of high concentration preparations (compared to non-crystalline mAbs) (pg 6934, paragraph 1) through an IgG mAb example (pg 6934, paragraph 3; pg 6938, “results and discussion”). Finally, Yang teaches a crystalline antibody viscosity of 26 cps (or 0.26 Pa-s) (at 150 mg/mL concentration) compared to 275 cps (at 150 mg/mL concentration) for soluble antibody (pg 6936, Fig 3), and no aggregation (reads on less than or equal to 10 wt% of the crystals are aggregated) at 200 mg/mL (pg 6938, paragraphs 3 and 4). With respect to the shear rate (of the dynamic viscosity in instant claim 32), the U.S. Patent Office is not equipped with analytical instruments to test prior art compositions for the infinite number of ways that a subsequent applicant may present previously unmeasured characteristics. When as here, the prior art appears to contain the exact same ingredients and applicant's own disclosure supports the suitability of the prior art composition as the inventive composition component, the burden is properly shifted to applicant to show otherwise. “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Shenoy teaches high concentration protein formulations (e.g., 150-300 mg/mL, Shenoy – claim 1) where the viscosity can be lowered by viscosity reducing agents (i.e. “excipient”) (abstract, figure 3). Shenoy teaches viscosities less than 50 cP (i.e., 0.05 Pa-s), where the excipient provides approximately a 5-10 fold reduction in viscosity of the solution (Figure 3, Shenoy – claim 1). Shenoy teaches the desirability to reduce viscosity and/or aggregation in protein formulations for drug delivery [0002]. Notably, Shenoy teaches solutions and suspensions (Shenoy - claim 41, [0142]), where the viscosity-reducing excipient and effect is applicable (Shenoy – claims 1-3, 12-15, 27-34).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the hydrogel antibody drug delivery formulation of Chandrashekhar with the crystalline mAb of Yang because there is motivation to substitute a crystalline mAb for a regular antibody such that crystalline mAbs overcome the issues of high viscosity, aggregation, and poor stability of high concentration preparations (compared to non-crystalline mAbs) (pg 6934, paragraph 1). This is exemplified by the absence of aggregation and low viscosity of high concentration crystalline mAb compositions of Yang (pg 6934, paragraph 3). Thus, if the input crystalline polypeptide demonstrates no aggregation (reads on less than or equal to 10 wt% of the crystals are aggregated) at 200 mg/mL (pg 6938, paragraphs 3 and 4), a PHOSITA would expect less than or equal to 10 wt% aggregation of a crystalline polypeptide formulation, comprising one or more hydrogels in association (reads on instant claim 3).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify a crystalline antibody formulation, as taught by Chandrashekhar and Yang, that incorporates excipients that reduce the viscosity of the resulting formulation (as taught by Shenoy) such that the viscosity of the composition would be lower than an aqueous suspension having equivalent concentration of crystalline polypeptides (i.e., Yang teaches 200 mg/mL and Shenoy teaches 150-300 mg/mL, as appropriate drug delivery concentrations) (reads on instant claim 2). The Examiner reiterates the indefiniteness of the term “otherwise essentially identical conditions” as discussed in the 112b rejection. The incorporation of viscosity reducing excipients is motivated because Shenoy teaches the desirability to reduce viscosity and/or aggregation in protein formulations for drug deliver [0002]. Notably, Shenoy teaches solutions and suspensions (Shenoy - claim 41, [0142]), where the viscosity-reducing excipient and effect is applicable (Shenoy – claims 1-3, 12-15, 27-34). Thus, the combined Prior Art teaches a scenario where a crystalline polypeptide in combination with a viscosity reducing excipient has a lower viscosity compared to an aqueous suspension of that peptide (reads on instant claim 2).
In addition, Ickenstein has directly suggested improving drug loading capacity in hydrogels by using crystalline proteins (pg 227-228, ‘conclusion & future perspective’), explicitly stating a direct motivation of replacing the antibodies of Chandrashekhar’s hydrogels with the crystalline antibodies of Yang. Thus, the discussed Prior Art are all interested in different aspects of improving mAb delivery through reduction of viscosity/aggregation and improvement in stability and teaching crystalline mAbs and hydrogel formulations as ways to accomplish this.
Claims 1, , 8-9, 11, 13, 17, 19-21, 23-24, 33, and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Chandrashekhar (US20020151650A1), in further view of Alvarez (WO2017191323A1; provided in Japanese Office Action from newly filed IDS on 10/24/2025).
As discussed above, Chandrashekhar teaches the specific limitations of claims 1, 8-9, 11, 13, 17 19-21, 23-24, 33, and 35. In particular, Chandrashekhar teaches proteins (e.g., an antibody) encapsulated in hydrogel particles.
However, Chandrashekhar does not explicitly teach incorporation of “a crystal comprising a solid form of a polypeptide” into the hydrogel formulation (instant claim 1).
Alvarez teaches pharmaceutically active protein crystals (such as insulin) within a hydrogel formulation (abstract), which is useful for drug delivery by injection (pg 13, section 5.1). Alvarez teaches the hydrogel can be cross-linked polymer that is made of agarose, gelatin, PEG for example (Alvarez – claims 1-2)
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the hydrogel particles of Chandrashekhar to incorporate a crystalline polypeptide (such as an antibody), as taught by Alvarez (demonstrating crystalline insulin incorporation into a hydrogel) because Alvarez teaches that crystalline mAb with a hydrogel formulation can provide unique pharmacokinetic behavior (i.e., release profile) (Example 5 on pg 13-16) and better stability (pg 1-2, ‘background of invention’).
Response to Arguments
Applicants arguments, see pg 6-11, filed 10/24/2025, with respect to the 103 rejection of claims 1-3, 5-6, 8-9, 11, 13, 17, 19-21, 23-24, 32-33, 35-37 under rejection have been fully considered, but they are not persuasive. The 103 rejection has been modified with respect to amendments made to the claim set and new added claims.
On page 6-7 (claim 1), Applicant argues that there is “no reasonable expectation of success” for the proposed modification to obtain “intact, stable, and functional antibodies” (as stated on page 7 and 9 of arguments) within the hydrogel carriers. “Applicants are reminded that obviousness does not require absolute predictability. See In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976) (indicating that evidence showing there was no reasonable expectation of success may support a conclusion of nonobviousness).” Thus, a proper rationale has been provided to combine the Prior Art references with regard to an obviousness rejection. Applicant has provided no evidence to rebut the obviousness rejection. Furthermore, Applicant has not provided evidence that a skilled artisan would not have the capacity to conduct the proposed modification to obtain “intact, stable, and functional antibodies” within the hydrogel carriers.
On page 7 (claim 1), Applicant argues Ickenstein points out “disadvantages and pitfalls” of loading hydrogels with antibodies. In contrast to the general statement Applicant attempts to leverage, Ickenstein directly suggests improving drug loading capacity in hydrogels by using crystalline proteins (pg 227-228, ‘conclusion & future perspective’), explicitly stating a direct motivation of replacing the antibodies of Chandrashekhar’s hydrogels with the crystalline antibodies of Yang. The Examiner further notes that Yang teaches crystallization of proteins such as mAbs to overcome the issues of high viscosity, aggregation, and poor stability of high concentration preparations (compared to non-crystalline mAbs) (pg 6934, paragraph 1). Thus, the references affirm motivation for the obviousness rejection: “Applicants are reminded that obviousness does not require absolute predictability. See In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976) (indicating that evidence showing there was no reasonable expectation of success may support a conclusion of nonobviousness).” Such that, a PHOSITA would expect lower aggregation of crystalline mAbs within a hydrogel formulation, when Yang further teaches that crystalline monoclonal antibodies (mAbs) overcome the issues of high viscosity, aggregation, and poor stability of high concentration preparations (compared to non-crystalline mAbs) (pg 6934, paragraph 1). Because Chandrashekhar teaches mAb hydrogel particle formulations as enabled for a PHOSITA, a PHOSITA would have a reasonable expectation of formulation crystalline mAbs in hydrogel formulations because Yang teaches crystalline monoclonal antibodies to be more stable than non-crystalline mAbs. This is sufficient rationale to maintain the obviousness of the rejection that combines a crystalline mAb with a hydrogel formulation.
Furthermore, the above arguments attempt to establish the lack of enablement of the combined Prior Art. A reference contains an "enabling disclosure" if the public was in possession of the claimed invention before the date of invention. "Such possession is effected if one of ordinary skill in the art could have combined the publication’s description of the invention with his [or her] own knowledge to make the claimed invention." In re Donohue, 766 F.2d 531, 226 USPQ 619 (Fed. Cir. 1985). Remember that Affidavits or declarations attacking the operability of a patent cited as a reference must rebut the presumption of operability by a preponderance of the evidence. In re Sasse, 629 F.2d 675, 207 USPQ 107 (CCPA 1980). Thus, there is motivation for the proposed modification with respect an obviousness rejection. Furthermore, Applicant has not provided sufficient data or evidence to demonstrate inoperability of a hydrogel particle loaded with crystalline polypeptide, as suggested by the combined Prior Art.
Additionally, in light of Applicant’s suggestion of the unpredictability of formulating crystalline mAb hydrogel formulations, the Examiner has taken notice of the specific centrifugal extrusion method required to form the mAb hydrogel formulation (Example 6, figure 25). If Applicant deems the method to impart a structural difference separate from the compositions made obvious by the Art, this could provide weight to the claim in terms of a product-by-process approach or otherwise demonstrate non-obviousness. As stated in MPEP 2172.01, “a claim which fails to interrelate essential elements of the invention as defined by applicant(s) in the specification may be rejected under 35 U.S.C. 112(b) or pre-AIA 335 U.S.C. 112, second paragraph, for failure to point out and distinctly claim the invention.” Thus, a demonstration of unexpected results may not be commensurate in scope with the claims, if the method of making the composition is not provided in the claim language, based on the potential unpredictability of formulation crystalline mAb hydrogel particles. For unexpected results arguments, in addition to data referred to in the Specification, any additional evidence provided to the application should be in the form of an Affidavit/Declaration.
On page 8 (claim 2), Applicant argues the dynamic viscosity limitation with attention drawn to the Examiner’s use of Yang. The Examiner agrees with the Applicant’s position that the comparison of viscosity soluble mAb to crystalline mAb suspension is not the same as the comparison of “a crystal comprising a solid form of a polypeptide at least partially encapsulated by the hydrogel particle” to crystalline mAb suspension.
Therefore, the Examiner has issued a second non-final action to address the patentability of claim 2, but in order to also provide clarity on the overall breadth of the instant claims with respect to Applicant’s disclosure in the Specification (i.e., there appears to be a reliance on a particular method making the crystalline mAb hydrogel formulation) and the overall technical challenges known to formulating crystalline antibodies in hydrogels (as discussed by the Art and within Applicant’s arguments). See new rejections above.
On page 8-9 (claim 3), Applicant argues the lack of aggregation is only demonstrated in Yang in a PEG/ethanol mixture rather than within a hydrogel. Note that in an obviousness rejection, all elements are not required: All elements of each prior art reference need not read on the claimed invention, rather, the proper test for obviousness is what the combined teachings would have suggested to a person of ordinary skill in the art. In re Kotzab, 217 F.3d 1365, 1370 (Fed. Cir. 2000). In this case, the PEG/ethanol mixture demonstration is a specific teaching that exemplifies Yang’s general teachings. Yang teaches crystalline antibodies are less prone to aggregation than mAbs, in high concentration settings (introduction). Yang also teaches a crystalline antibody with no aggregation (reads on less than or equal to 10 wt% of the crystals are aggregated) at 200 mg/mL (pg 6938, paragraphs 3 and 4). Ickenstein directly suggests improving drug loading capacity in hydrogels by using crystalline proteins (pg 227-228, ‘conclusion & future perspective’), explicitly stating a direct motivation of replacing the antibodies of Chandrashekhar’s hydrogels with the crystalline antibodies of Yang. Thus, in the context of the claimed composition, it would be obvious to improve higher loadings and reduced aggregation of the hydrogel formulations of Chandrashekar by way of crystalline antibodies because crystalline antibodies themselves are known for having low aggregation. Therefore, the combined limitations of claim 3 are obvious.
As for the lack of rationale suggested for a crystalline monoclonal antibody to maintain a low aggregation percentage in carriers/formulations of Chandrashekhar, Yang teaches that crystalline monoclonal antibodies (mAbs) overcome the issues of high viscosity, aggregation, and poor stability of high concentration preparations (compared to non-crystalline mAbs) (pg 6934, paragraph 1) and that crystalline proteins offer high stability, streamlining of manufacturing, controlled release of activity, and high doses at the deliver site (pg 6934, paragraph 2), which provides adequate motivation for combination in an obviousness rejection. Thus, the combined references still demonstrate the obviousness of instant claim 3 as written.
In terms of the Office demonstrating how a PHOSITA would have “reasonably expected” same lack of aggregation (which is an intended result, where motivation was already demonstrated for combination) by combining Yang and Chandrashekar: “Applicants are reminded that obviousness does not require absolute predictability. See In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976) (indicating that evidence showing there was no reasonable expectation of success may support a conclusion of nonobviousness).” Thus, Yang demonstrates a crystalline antibody formulation with no aggregation (reads on less than or equal to 10 wt% of the crystals are aggregated) at 200 mg/mL (pg 6938, paragraphs 3 and 4) (also suggesting that crystalline mAbs overcome the issues of high viscosity, aggregation, and poor stability of high concentration preparations (compared to non-crystalline mAbs) (pg 6934, paragraph 1)) and Chandrashekhar and Alvarez each teach the obviousness of antibodies formulated as hydrogels. In terms of an obviousness rejection, a PHOSITA would expect similarly low aggregation when the protein is associated with a hydrogel formulation because Yang teaches crystalline mAb formulations with low aggregation and Chandrashekhar and Alvarez teach the obviousness of incorporating crystalline mAbs into hydrogel (reading on instant claim 3). Applicant has not provided sufficient data or evidence to suggest inoperability of the proposed combination of a crystalline antibody associated with a hydrogel particle as taught by the Prior Art, such that the combination would lead to increased aggregation or some other failure.
Finally, the reiteration and summary of arguments, discussing the teachings of Ickenstein and the rebuttal to the “reasonable expectation of success” is addressed in the previous paragraphs.
On pages 9-11, Applicant summarizes their position.
Correspondence
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/R.P./Examiner, Art Unit 1614 12/1/2025
/SEAN M BASQUILL/Primary Examiner, Art Unit 1614