DETAILED ACTION
The finality of the rejection of the last Office action was reconsidered and the finality of that action is withdrawn.
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 .
Claim Status
The claim listing filed October 8, 2025 is pending. Claims 1, 2, 6, 7, 13, 17, 22-24, 27 are amended. Claims 28-30 are new. Claims 3, 5, 8, 14-16, 18, 19, 21, and 25 were canceled. 1, 2, 4, 6, 7, 9-13, 17, 20,22-24,and 26-30 are pending and under examination.
Priority
This application is the national stage of international application PCT/EP2024/059850, filed April 11, 2024 and claimed priority to foreign application BE2023/5269 filed in The Kingdom of Belgium on April 11, 2023. Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Rejections - 35 USC § 112(b)
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.
Claim 24 is 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 24 recites the limitation, wherein the recovered product is selected from the group consisting of a polyglycol ether of a fatty alcohol and a polyglycol ether of a fatty alcohol that comprise Laureth-9. The claim depends from claims 1 and 20. The recovered product is obtained method the claims the recovering step is “recovering a collagen-containing and/or collagen-derived product”. See claim 1. Claim 24 is indefinite because a polyglycol ether of a fatty alcohol and a polyglycol ether of a fatty alcohol that comprise Laureth-9 is not collagen-containing or collagen-derived as it does not contain collagen nor is it is derived from collagen. Therefore, the metes and bounds of the claim are unclear.
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.
Claim 20, 22, 23 and 26 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a production of nature without significantly more. Claim 20 recites a collagen-containing and/or collagen-derived product, obtainable by the method of claim 1. The claims recite a natural product. This judicial exception is not integrated into a practical application because is it directed to purified collagen products. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the reasons set forth below.
Step 1: Does the claim fall into a statutory category of invention? Yes, the claim is directed to a collagen-containing and/or collagen-derived product.
Step 2A:: Is the claim directed to a law of nature, a natural phenomenon (product of nature) or an abstract idea? Yes, the claim is directed to a product of nature. The claimed collagen-containing and/or collagen-derived product includes naturally occurring products like gelatin and human collagen. The markedly different characteristics analysis is part of Step 2A Prong One. The markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state, the first step in the analysis is to select the appropriate counterpart(s) to the nature-based product.
Step 2A Prong One: Does the claim recite an abstract idea, law of nature or natural phenomenon?. In the present case, the answer is yes because when a nature-based product is derived from a naturally occurring thing, then the naturally occurring thing is the counterpart. MPEP §2106.04 (c)(II) (A). The naturally occurring counterpart to the claimed collagen-containing and/or collagen-derived product is collagen or gelatin.
Step 2A Prong Two: Does the claim recite additional elements that integrate the judicial exception into a practical application? Because the markedly different characteristics analysis is based on comparing the characteristics of the claimed nature-based product and its counterpart, the second step in the analysis is to identify appropriate characteristics to compare. Appropriate characteristics must be possessed by the claimed product, because it is the claim that must define the invention to be patented. In the present case, the structural and functional characteristics of the claimed collagen-containing or collagen-derived products encompass gelatin and collagen which are not different from that which occurs in nature.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception? No, the additional limitation “obtainable by the method of claim 1” does not change the structure of the collagen-containing or collagen-derived products like gelatin and collagen, therefore, the limitation does not amount to significantly more than the judicial exception. There is no evidence of record that the collagen-containing or collagen-derived products specifically functions or is structurally different from its closest naturally counterpart, gelatin or collagen.
Therefore, claims 20, 22, 23 and 26 are ineligible under 35 U.S.C. 101.
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)(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.
Claim 20, 22, 23 and 26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Olijve et al. (US 10,155,805 B2; 2018).
Regarding claims 20 and 26, Olijve et al. disclose gelatin with an LPS concentration of 32-5 EU/g. See Table 15.
Regarding claims 22 and 23, the gelatin comprises no Laureth-9 (less than 0.1 ppm).
Claims 20, 22 and 23 are recited product-by-process limitation (i.e., obtainable by the method of claim 1), “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
Therefore, the disclosures of Olijve et al. anticipate the instantly claimed invention.
Claim 20 and 22-24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hunter et al. (WO 2022/003565A1; published 2022).
Hunter et al. teach Laureth-9. See the abstract.
Claims 20 and 22-24 are recited product-by-process limitation (i.e., obtainable by the method of claim 1), “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
Therefore, the disclosures of Hunter et al. anticipate the instantly claimed invention.
Claim Rejections - 35 USC § 103
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 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.
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 1, 2, 4, 6, 7, 9-13, 17 and 27-30 are rejected under 35 U.S.C. 103 as being unpatentable over Olijve et al. (US 10,155,805 B2; 2018) in view of Hunter et al. (WO 2022/003565A1; published 2022).
The teachings of Olijve et al. are directed to the removal of lipopolysaccharides from aqueous mediums comprising gelatin utilizing TRITON X-100. See e.g., the abstract, Examples 1-14; claims 1-14.
The difference between the instantly claimed invention and the teachings of Olijve et al is the use of a polyglycol ether of a fatty alcohol such as Laureth -9 for the removal of lipopolysaccharides.
Hunter et al. describe methods of removing endotoxins, lipopolysaccharides, from biotherapeutics using an environmentally compatible detergent comprising Laureth-9 (polyglycol ether of a fatty alcohol). Hunter et al. teach Laureth-9 advantageously does not adversely impact product quality. See the e.g., abstract. Hunter et al. teach the endotoxins are removed from a biotherapeutic of interest by contacting the biotherapeutic with the environmentally compatible detergent comprising Laureth-9 and recovering the biotherapeutic of interest. See §Endotoxin removal. Hunter et al. further teach obtaining purified product (eluate) with endotoxin concentrations as low as below 0.1 EU/mg/ See p. 28, 1st ¶. Hunter et al. teach the use of Laureth-9 does not increase the amount of product variants in the product stream as compared to a purification process in which Triton X-100 is used as a surfactant. See p. 22, lines 17-21.
At the time before the effective filing date of the instant invention, it would have been prima facie obvious to substitute Laureth-9 taught by Hunter et al. for TRITON X-100 in the process of Olijve et al. to remove the endotoxins (LPS). An artisan of ordinary skill in the art would have been motivated to apply Laureth-9 to the LPS-containing aqueous gelatin medium of Olijve et al. with the expectation that the product quality would not be adversely affected with a reduction in the amount of product variants produced. There would a reasonable expectation of success because Hunter et al. demonstrated removal of endotoxin from a protein composition using Laureth-9; achieving an endotoxin concentration below 1 EU/mg . See Example 5 ,¶¶[0135-0141].
Regarding claim 2, Olijve et al. teach gelatin. See e.g., claim 1.
Regarding claim 4, the medium (composition) is aqueous. See e.g., claim 1.
Regarding claim 6, Olijve et al. teach the composition comprise at least 2 w/w% to up to 30 w/w% or even higher gelatin. See col. 9, lines 25-45; Examples 1-14, claims 1, 8. Because the claimed range overlaps with the range disclosed by the prior art, a prima facie case of obviousness exists.
Regarding claims 7, 9, 29 and 30, Hunter et al. teach Laureth-9 (polyglycol ether of laurel alcohol). See. Laureth-9 has a chain of 9 ethylene oxide units.
Regarding claims 10 and 11, Hunter et al. teach utilizing at least about 0.1 w/v% up to 10 w/v% Laureth-9. See p.27; 1st ¶, p. 29, 1st ¶; claims 19 and 32. The density of Laureth-9 is about 0.96-0.97 g/ml, evidenced by. Utilizing this conversion, 0.1 w/v% up to 10 w/v% Laureth-9 is equivalent to approximately 0.1 w/w% up to 10 w/w% Laureth-9. Because the claimed range overlaps with the range disclosed by the prior art, a prima facie case of obviousness exists. Furthermore, routine optimization of an efficacious amount of Laureth-9 would have lead the skill artisan to any appropriate amount including the amounts claimed because Hunter et al. shows 1% w/v of Laureth- 9 effectively removes endotoxin from a protein containing composition. See Example 5.
The density of Laureth-9 is approximately 0.96–0.97 g/mL, and using this conversion the disclosed range of 0.1–10 w/v% corresponds approximately to 0.1–10 w/w% Laureth-9. Because the claimed range overlaps the range disclosed by the prior art, a prima facie case of obviousness exists. Moreover, routine optimization of Laureth-9 concentration would have been within the skill of an ordinary artisan, further supporting a finding of obviousness.
Regarding claim 12, both Olijve et al. teach contacting the composition with an adsorbent. See the e.g., abstract; Example 3.
Regarding claim 13, Olijve et al. teach the adsorbent is solid or comprises activated carbon. See the e.g., abstract; col. 17, lines 14-20.
Regarding claim 17, Olijve et al. teach recovering purified biotherapeutic/gelatin by filtration. See col. 6, lines 65-67; col. 7, lines 5-7; col. 8, lines 21-25; col. 17, lines 5-8.
Regarding claim 27, Olijve et al. teach for medical applications (e.g., implants and devices), the endotoxin (LPS) content should be preferably ≤10 EU/g. See col. 2, lines 34-46. Although Olijve et al. do not expressly teach providing gelatin in a medical device as claimed, it would have been obvious to provide purified gelatin for such use in view of Hunter et al. which demonstrate using Laureth-9 can reduce endotoxin levels to very low concentrations (e.g., as low as 1 EU/mg).
Regarding claim 28, Olijve et al. teach the recovered gelatin is in an aqueous medium. See e.g., claim 15.
Therefore, before the effective filing date of the claimed invention, the instantly claimed invention was prima facie obvious to the artisan of ordinary skill.
Summary
Claim 24 is rejected under 35 U.S.C. 112(b). Claim 20, 22, 23 and 26 are rejected under 35 U.S.C. 101. Claim 20, 22-24 and 26 are rejected under 35 U.S.C. 102(a)(1). Claims 1, 2, 4, 6, 7, 9-13, 17 and 27-30 are rejected under 35 U.S.C. 103. No claim is allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Lianko G Garyu whose telephone number is (571)270-7367. The examiner can normally be reached Monday through Friday 8:30 AM - 5:00 PM.
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Lianko G. Garyu, Ph.D.
Supervisory Patent Examiner
Art Unit 1654
/LIANKO G GARYU/Supervisory Patent Examiner, Art Unit 1654